Noninferiority Study Comparing Latanoprost 0.005% Without Versus With Benzalkonium Chloride in Open-Angle Glaucoma or Ocular Hypertension.

OBJECTIVES: To evaluate the noninferiority of intraocular pressure (IOP)-lowering latanoprost without benzalkonium chloride (BAK) versus latanoprost with BAK (for treatment of open-angle glaucoma or ocular hypertension). METHODS: Overall, 578 patients were randomized 1:1 to latanoprost without BAK or latanoprost with BAK once daily in the affected eye(s) for 12 weeks. The primary efficacy endpoint was IOP, measured on days 0, 7, 28, 56, and 84 (8 am, 10 am, and 4 pm). Noninferiority was established if the following criteria were met: 95% confidence interval (CI) of the mean difference between treatments included 0 mm Hg for all time points (N1), 95% CI upper limit less than 1.5 mm Hg (N2), and less than 1 mm Hg for≥7 of 12 time points (N3). Primary efficacy analysis was performed on the intent-to-treat population. Safety measurements included ocular and systemic adverse event (AE). RESULTS: The 95% CI included 0 mm Hg for 7/12 time points (N1), 95% CI upper limit was less than 1.5 mm Hg for 12/12 time points (N2), and less than 1.0 mm Hg for 4/7 time points (N3). AEs were mild and similarly distributed between groups. CONCLUSIONS: Latanoprost without BAK did not meet two of three criteria for noninferiority and showed a similar safety profile relative to latanoprost with BAK.

Efficacy and Safety of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, for the Treatment of Keratoconjunctivitis Sicca: Pooled Analysis of a Phase 2b/3 and Phase 3 Study.

BACKGROUND: OTX-101 (CEQUA™) is approved in the United States for treatment of keratoconjunctivitis sicca (KCS). This pooled analysis of 2 studies (phase 2b/3 and phase 3) evaluates the efficacy and safety of OTX-101 0.09% in the intent-to-treat (ITT) population and the subgroup of patients with a baseline Schirmer score less than 10 mm. METHODS: In these randomized, multicenter, double-masked, vehicle-controlled studies, patients received 1 drop of either OTX-101 or vehicle in both eyes twice daily. A Schirmer's test was performed at baseline and day 84/early discontinuation. Symptom Assessment iN Dry Eye (SANDE) scores and adverse events were monitored at each visit. RESULTS: The pooled analysis included 523 and 525 patients randomized to OTX-101 0.09% and vehicle, respectively. In the ITT population, 16.6% of eyes receiving OTX-101 and 9.0% of eyes receiving vehicle showed a day 84 increase in Schirmer score ≥10 mm from baseline (P<0.0001). In the subgroup with Schirmer score less than 10 mm at baseline, 18.7% and 10.2% of eyes receiving OTX-101 and vehicle, respectively, exhibited this outcome (P=0.0001). The mean (SD) percent change from baseline in global SANDE scores on day 84 in the ITT population was -29.0% (39.0%) and -30.4% (39.5%) for OTX-101 and vehicle groups, respectively. In the subgroup, the mean (SD) percent change was -27.3% (39.7%) and -31.4% (38.3%) for OTX-101 and vehicle groups, respectively. Adverse events were mostly mild to moderate. CONCLUSIONS: OTX-101 improved tear production compared with vehicle. Both OTX-101 and vehicle showed improved SANDE scores over baseline. OTX-101 was well tolerated in patients with KCS.

A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease.

PURPOSE: To evaluate the safety and efficacy of OTX-101, a novel aqueous nanomicellar formulation of cyclosporine (0.09%), in the treatment of patients with dry eye disease (DED). DESIGN: A randomized, multicenter, vehicle-controlled, double-masked, phase 3 clinical trial. PARTICIPANTS: Adults (18-90 years of age) with a history and clinical diagnosis of DED, a global symptom score of 40 or more (range, 0-100), and a lissamine green conjunctival staining score of 3 or more and 9 or less (range, 0-12) in at least 1 eye. METHODS: Eligible patients entered a run-in period of 14 to 20 days in which all patients administered vehicle twice daily. Patients who remained eligible at the baseline (day 0) visit were randomized in a 1:1 ratio to twice-daily treatment with OTX-101 0.09% or vehicle for 84 days. MAIN OUTCOME MEASURES: Efficacy assessments included signs (unanesthetized Schirmer tear test, corneal and conjunctival staining) and symptoms (global symptom score) of DED. The primary end point was the proportion of eyes with a clinically meaningful improvement (increase of ≥10 mm) in Schirmer test score at day 84. Safety evaluations included adverse events (AEs), visual acuity, and intraocular pressure monitoring, slit-lamp, dilated ophthalmoscopy, and fundus examinations. RESULTS: A total of 744 patients were randomized and received study medication (371 to OTX-101 0.09% and 373 to vehicle). The primary end point was achieved; a significantly greater percentage of eyes in the OTX-101 0.09% treatment group achieved an increase of 10 mm or more in the Schirmer test score at day 84 (OTX-101 0.09%, 16.6%; vehicle, 9.2%; P < 0.001). Significant improvements relative to vehicle also were observed for corneal (days 28, 56, and 84) and conjunctival (days 56 and 84) staining. The global symptom score was reduced from baseline in both treatment groups by approximately 30%; however, no significant separation between groups was observed. The OTX-101 0.09% formulation was well tolerated. Treatment-emergent AEs were primarily mild in intensity. CONCLUSIONS: Clinically and statistically significant improvements in tear production and ocular surface integrity were observed in patients treated with OTX-101 0.09% for DED.

Dysfunctional tear syndrome: dry eye disease and associated tear film disorders - new strategies for diagnosis and treatment.

Dysfunctional tear syndrome (DTS) is a common and complex condition affecting the ocular surface. The health and normal functioning of the ocular surface is dependent on a stable and sufficient tear film. Clinician awareness of conditions affecting the ocular surface has increased in recent years because of expanded research and the publication of diagnosis and treatment guidelines pertaining to disorders resulting in DTS, including the Delphi panel treatment recommendations for DTS (2006), the International Dry Eye Workshop (DEWS) (2007), the Meibomian Gland Dysfunction (MGD) Workshop (2011), and the updated Preferred Practice Pattern guidelines from the American Academy of Ophthalmology pertaining to dry eye and blepharitis (2013). Since the publication of the existing guidelines, new diagnostic techniques and treatment options that provide an opportunity for better management of patients have become available. Clinicians are now able to access a wealth of information that can help them obtain a differential diagnosis and treatment approach for patients presenting with DTS. This review provides a practical and directed approach to the diagnosis and treatment of patients with DTS, emphasizing treatment that is tailored to the specific disease subtype as well as the severity of the condition.

Comparative Assessment of Oral Health Related Quality of Life in Chronic Periodontitis Patients of Rural and Urban Populations in Punjab.

PURPOSE: To assess and compare the oral health related quality of life in patients suffering from chronic periodontitis using the short questionnaire of oral health impact profile (OHIP-14) in rural and urban populations of Punjab state, India. MATERIALS AND METHODS: One hundred patients suffering from chronic periodontitis were screened and divided into two groups, rural and urban (50 participants in each group). The clinical parameters plaque index (PI), gingival index (GI), pocket probing depth (PPD) and OHIP-14 were assessed in all patients. RESULTS: The mean PI (2.11 ± 0.635), GI (1.61 ± 0.45), PPD (3.12 ± 0.692) and OHIP-14 (11.49 ± 9.733) scores were significantly higher in the rural than in the urban population (1.69 ± 0.45, 1.56 ± 0.355, 3.30 ± 0.973, 5.88 ± 5.588, respectively) suffering from chronic periodontitis. The most affected domain in the rural population was functional limitation, whereas psychological disability was the most affected in the urban population. A statistically significant positive correlation was observed between the periodontal parameters and OHIP-14 (p < 0.001) in both groups. CONCLUSION: Within the limitations of the study, periodontal status and oral health related quality of life are significantly correlated with each other in both rural and urban populations.

Open-Label Extension Study Comparing Latanoprost 0.005% Without vs With Benzalkonium Chloride in Open-Angle Glaucoma or Ocular Hypertension.

Purpose: To evaluate the long-term safety of latanoprost benzalkonium chloride (BAK)-free vs currently marketed latanoprost 0.005% ophthalmic solution containing BAK (referred to as reference), to treat open-angle glaucoma (OAG) or ocular hypertension (OHT). Patients and Methods: This phase 3, multicenter, open-label, nonrandomized, single group assignment, safety study included patients who previously completed a phase 3 noninferiority study. Patients self-administered 1 drop of latanoprost BAK-free nightly for 36 weeks in the affected eye(s). Intraocular pressure (IOP), visual acuity (VA), and slit lamp biomicroscopy were assessed predose at baseline and Days 28, 56, 84, 112, 140, and 168; dilated ophthalmoscopy and visual field (VF) at baseline and Day 168. Adverse events (AEs) were recorded throughout the study. Results: A total of 161 patients who previously received latanoprost BAK-free (n = 80) or reference (n = 81) were enrolled. Latanoprost BAK-free maintained lowered IOP for both the study and nonstudy eye in all patients relative to baseline throughout the study. Clinically significant retinal or optic nerve changes were identified in 5 patients (1 mild-to-moderate change, prior latanoprost BAK-free; 4 mild changes, prior reference). No clinically important changes were identified for VA, slit lamp biomicroscopy, and VF measurements. Ocular AEs occurred in 66 (82.5%) vs 74 (91.4%) patients on prior latanoprost BAK-free and reference, respectively; the most frequent being eye pain (50.0% vs 64.2%) and ocular hyperemia (47.5% vs 54.3%). Most AEs were mild. There were 5 serious systemic AEs in 5 patients (n = 3, prior latanoprost BAK-free; n = 2, prior reference); all were considered unrelated or not likely related to treatment. One patient (prior reference) discontinued due to follicular conjunctivitis. There were no deaths or serious ocular AEs. Conclusion: Latanoprost BAK-free was well tolerated. These findings support the chronic use of latanoprost BAK-free to treat OAG or OHT. Clinical Trial Registration Number: NCT00945958.

Functionally graded membrane: A novel approach in the treatment of gingival recession defects.

BACKGROUND: Guided tissue regeneration has recently been advocated in re-constructing soft-tissue dimensions in recession defects. Advancement in nanotechnology has led to increased zest for approaches such as electrospinning of biologically active; nanofibrous functionally graded regenerative membranes for periodontal tissue engineering. A functionally graded membrane (FGM) had been tailored by incorporating chitosan and nano-hydroxyapatite over Amnion membrane and used in gingival recession defects. STUDY DESIGN: It was single-blind, randomized controlled study. Split-mouth study was conducted in nine patients and 22 sites with recession defects were selected. Sites were divided into Group A (Amnion membrane with coronal advanced flap) and Group B (FGM with coronal advanced flap). MATERIALS AND METHODS: Sites were assessed clinically by recording plaque index (PI), gingival index (GI), vertical recession defect depth (VRDD), relative clinical attachment level (CAL), and width of keratinized tissue at baseline, 3-6 months; and radiographically by recording linear bone growth by dentascan at baseline and 6 months. RESULT: Both groups showed statistically significant reduction in PI, GI and VRDD, and CAL and nonsignificant reduction in width of keratinized tissue at 3 and 6 months postoperatively. Group A showed statistically significant linear bone growth at 6 months. Group B also showed gain in linear bone growth at 6 months; however, result was statistically nonsignificant. CONCLUSION: FGM had shown favorable results by enhancing bone growth while preventing the gingival tissue downgrowth.

Evaluation of Curcumin Gel as Adjunct to Scaling & Root Planing in Management of Periodontitis- Randomized Clinical & Biochemical Investigation.

BACKGROUND: Successful management of periodontitis requires treatment strategy that integrates therapies addressing both pathogen and host aspects of disease etiology. To evaluate sub gingivally applied curcumin gel in treatment of chronic periodontitis based on clinical and biochemical parameters. MATERIALS & METHODS: A randomized, double blind, parallel-group trial was carried out on 30 patients suffering from chronic generalized periodontitis with probing pocket depth≥5mm on at least 4 sites who were then randomly allocated to two groups. Control group was treated with Scaling and Root Planing (SRP) alone while experimental group was treated with SRP followed by subgingival application of curcumin gel. Saliva collection was done and the clinical parameters were recorded at baseline and follow up periods. Saliva analysis for IL-1ß was done by ELISA. The statistical differences for the intra-group and intergroup measurements were analyzed by using Mann Whitney test. Spearman's rank correlation coefficient was used to examine the relationship between Interleukin - 1ß and clinical parameters. RESULTS: Study elucidated mild adjunctive benefit of curcumin gel in reduction of gingival inflammation for a limited period of time. Though improvement in other clinical parameters was also greater in subjects treated with curcumin gel, results were not statistically different from those treated with SRP alone. None of the subjects who received curcumin gel experienced any adverse effect. CONCLUSION: Within limitations, it can be concluded that single application of curcumin (turmeric) gel has limited added benefit over scaling and root planing in treatment of chronic periodontitis.

Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects.

PURPOSE: The studies reported here aimed to assess the safety and tolerability of cetirizine ophthalmic solution 0.24%, a new topical ophthalmic medication approved by the US Food and Drug Administration for the treatment of ocular itching associated with allergic conjunctivitis. PATIENTS AND METHODS: Three clinical studies evaluated cetirizine ophthalmic solution 0.24% administration: a Phase I prospective, single-center, open-label, pharmacokinetic (PK) study (N=11) evaluating single-dose administration and twice-daily (BID) administration for 1 week in healthy adults, and two Phase III, multi-center, randomized, double-masked, vehicle-controlled, parallel-group studies evaluating the safety and tolerability in adult and pediatric populations (2-18 years of age) for up to 6 consecutive weeks. The first safety and tolerability study evaluated cetirizine BID (study 1, N=512), while the second study examined cetirizine three times daily (TID) (study 2, N=516). Each study assessed best corrected visual acuity, slit-lamp biomicroscopy, IOP, dilated ophthalmoscopy, treatment-emergent adverse events, vital signs, urine pregnancy test, and physical examination (general health, head, eyes, ears, nose, and throat). The PK study also measured hematology, blood chemistry, and urinalysis, while the two Phase III studies additionally assessed corneal endothelial cell counts (ECC) and ECC density in a subset of subjects (via specular microscopy), and drug administration tolerability. RESULTS: Bilateral administration of cetirizine ophthalmic solution 0.24% resulted in low systemic exposure in the PK study and was associated with a low incidence of mild adverse events. There were no drug-related severe or serious adverse events. The tolerability scores between the active and vehicle groups were comparable, demonstrating high comfort in the administration of cetirizine ophthalmic solution 0.24%. CONCLUSION: Cetirizine ophthalmic solution 0.24% dosed BID or TID demonstrated an acceptable safety profile and was well-tolerated when administered to subjects aged ≥2 years.

Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Corneal Staining in Patients With Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies.

BACKGROUND: Keratoconjunctivitis sicca affects 5% to 33% of the population and is often accompanied by symptoms such as burning and dryness. This pooled analysis evaluated total and central corneal fluorescein staining (CFS) in patients receiving OTX-101 0.09% or vehicle in phase 2b/3 and 3 studies and whether improvements in corneal staining correlated with improved visual acuity. METHODS: In these randomized, vehicle-controlled studies, patients received 1 drop of OTX-101 or vehicle in both eyes twice daily. Corneal staining was performed at baseline and days 28, 56, and 84. CFS was evaluated in each zone (0-to-4 scale); total corneal staining (0-to-20 scale per eye) was averaged over both eyes. Pooled safety assessments included adverse event monitoring. RESULTS: Mean baseline CFS total scores (SD) were 4.2 (2.5) and 4.3 (2.6) for the OTX-101 (n = 523) and vehicle (n = 525) groups, respectively. For total corneal staining, least squares mean changes from baseline (standard error) were -0.9 (0.08) versus -0.5 (0.08) for OTX-101 and vehicle, respectively (P = 0.0008), on day 28 and -1.4 (0.09) versus -0.9 (0.09) on day 84 (P = 0.0002). There was a significantly high correlation (P = 0.0117) between reduced central corneal staining and improved visual acuity on day 84. Treatment-related adverse events were mostly mild, with instillation site pain reported by 21.8% and 4.0% of patients receiving OTX-101 and vehicle, respectively. CONCLUSIONS: Treatment with OTX-101 led to greater improvements versus vehicle in corneal surface staining as early as 4 weeks, and further improvements were seen up to 12 weeks. OTX-101 was well tolerated in patients with keratoconjunctivitis sicca.

Comparison of clinical effectiveness of single and multiple applications of 1% chlorhexidine varnish (Cervitec Plus) along with scaling and root planing in patients with chronic periodontitis.

BACKGROUND: Local drug delivery is most commonly used as an adjunct to scaling and root planing (SRP) for the treatment of periodontal disease. Varied success rates have been documented for various vehicles used for intrasite delivery of active therapeutic agents. Recently, varnishes acting as a reservoir of chlorhexidine have shown potential for the management of chronic periodontitis patients. The aim of the present investigation was a comparative evaluation of the clinical effectiveness of single and multiple applications of 1% chlorhexidine and thymol varnish (Cervitec Plus) along with SRP in patients with chronic periodontitis. MATERIALS AND METHODS: The present study included 30 patients with chronic periodontitis divided into three groups based on the number of subgingival applications of chlorhexidine varnish single application (Group A), two applications at a week's interval (Group B), and three applications with 7-day interval in between two applications (Group C). Clinical parameters, namely plaque index (PI), sulcus bleeding index, probing pocket depth (PPD), and relative attachment level (RAL) were recorded at baseline, 1 month and 3 months in all three groups to compare the clinical efficacy. RESULTS: A statistically significant reduction was observed in PI, sulcus bleeding index, PPD, and RAL at 1 and 3 months in all the three groups. Greater (though statistically nonsignificant) improvements were observed in Groups B and C. CONCLUSION: Within limitations of the study, it can be concluded that multiple applications of 1% chlorhexidine and thymol varnish (Cervitec Plus) have an added benefit over the single application in the treatment of chronic periodontitis.

Clinical and Microbiological Investigation of the Effects of Probiotics Combined with Scaling and Root Planing in the Management of Chronic Periodontitis: A Randomized, Controlled Study.

AIM: To assess the adjunctive effect of probiotics to scaling and root planing in the management of chronic periodontitis. MATERIALS AND METHODS: Thirty systemically healthy subjects in the age range of 20 - 55 years suffering from chronic generalized periodontitis were selected and randomly assigned to a control group of patients who received scaling and root planing (SRP) alone, or a test group of patients who received SRP supplemented with probiotic administration, i.e., Bifilac lozenges. The following baseline clinical parameters were recorded at selected teeth: plaque index, gingival index, probing pocket depth and relative attachment level. Microbiological counts of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Prevotella intermedia were assessed in pooled subgingival plaque samples. The parameters were recorded again at 30 days, 45 days and 3 months from baseline. RESULTS: Statistically significant reductions were observed for plaque index, gingival index, and probing pocket depth, and a significant gain in relative attachment level in both groups. Microbiological analysis showed significant reduction for P. gingivalis at all recall intervals in the test group compared to controls. The intergroup comparison for differences in mean counts of P. gingivalis was found to be significant for the test group at 3 months (p = 0.028). CONCLUSION: Probiotics can be considered as a potentially safe and effective adjunct to scaling and root planing in the management of chronic periodontitis.

Evaluation of bone morphogenic proteins in periodontal practice.

Forty years ago Marshal R. Urist discovered a substance in bone matrix that had inductive properties for the development of bone and cartilage, until date, at least 20 bone morphogenetic proteins (BMPs) have been identified, some of which have been shown in vitro to stimulate the process of stem cell differentiation into osteoblasts in human and animal models. The purpose of this paper is to give a brief overview of BMPs and to review critically the clinical data currently available on the use of BMPs in various periodontal applications. The literature on BMPs was reviewed. A comprehensive search was designed. The articles were independently screened for eligibility. Articles with authentic controls and proper randomization and pertaining specifically to their role in periodontal applications were included. The available literature was analyzed and compiled. The analysis indicates BMPs to be a promising, as well as an effective novel approach to reconstruct and engineer the periodontal apparatus. Here, we represent several articles, as well as recent texts that make up a special and an in-depth review on the subject. On the basis of the data provided in the studies that were reviewed BMPs provide revolutionary therapies in periodontal practice.

Correlation of alkaline phosphatase activity to clinical parameters of inflammation in smokers suffering from chronic periodontitis.

CONTEXT: Current clinical periodontal diagnostic techniques emphasize the assessment of clinical and radiographic signs of periodontal diseases which can provide a measure of history of disease. Hence, new methodologies for early identification and determination of periodontal disease activity need to be explored which will eventually result in expedited treatment. AIM: To evaluate the correlation of alkaline phosphatase (ALP) activity in gingival crevicular fluid (GCF) to clinical parameters of periodontal inflammation in smokers with chronic periodontitis. MATERIALS AND METHODS: Study population included 15 smoker male patients in the age group of 35-55 years suffering from moderate generalized chronic periodontitis with history of smoking present. Following parameters were evaluated at baseline, 1 month and 3 months after scaling and root planing: plaque index, bleeding index, probing pocket depth (PD), relative attachment level (RAL), and GCF ALP activity. STATISTICAL ANALYSIS USED: Independent variables for measurements over time were analyzed by using Wilcoxon signed rank test. RESULTS: A statistically significant reduction in all the clinical parameters and GCF ALP activity was observed from baseline to 1 month and 3 months. A correlation was observed between change in GCF ALP activity and PD reduction as well as gain in RAL at 3 months. CONCLUSION: The present study emphasizes that total ALP activity could be used as a marker for periodontal disease activity in smokers. Estimation of changes in the levels of this enzyme has a potential to aid in the detection of progression of periodontal disease and monitoring the response to periodontal therapy.

The Gender Bender effect in Periodontal Immune Response.

BACKGROUND: The gender and sex of an individual is known to have a significant bearing on the immune system, responsible for protection against infections and disease. Contemporary evidence suggests there exists a sexual dimorphism in the hetero immune as well as autoimmune responses in human beings and females show stronger and more vigorous immune responses to antigenic stimulations, e.g infectious diseases and vaccination. The evidence supportive to gender based heterogeneity in immune responses specifically in context of periodontal disease, is mounting in contemporary literature. METHOD: A thorough and methodical search for related scientific publications have been accomplished by using different key words and terms like sex or gender based immune differences in periodontal disease, both by manual methods and on various electronic databases. Primary research articles, narrative and systematic reviews of good quality, relevant to the subject were included. RESULTS: The aggregate effects of the factors related to gender such as the steroid hormones as well as gene based differences in both sexes as supported by published literature are in line with the observed variation in susceptibility for chronic periodontitis in both genders , with males showing more risk for disease than women. CONCLUSION: Gender as a risk factor for periodontal disease needs to identified, its underlying mechanisms to contribute needs to be revealed, so that novel strategies for risk assessment, disease identification and individualized therapeutic approaches can be developed for optimized patient care.

Exploring association between sleep deprivation and chronic periodontitis: A pilot study.

BACKGROUND: Sleep deprivation has become a global phenomenon, and epidemiologic data indicate that short sleep duration adversely impacts human physical health. Underlying mechanisms involve modulation of immune-inflammatory mechanisms. These changes might contribute to potentiation of destructive periodontal disease. Therefore, the present study aimed to assess if there is an association of sleep deprivation with chronic periodontal diseases. MATERIALS AND METHODS: Sixty subjects were categorized into 3 groups (n = 20 each) viz. clinically healthy, gingivitis and periodontitis. Periodontal status of subjects was assessed by gingival index and pocket probing depth. All the study subjects were administered Pittsburgh Sleep Quality Index (PSQI) questionnaire for the assessment of sleep deprivation. RESULTS: Present investigation revealed that mean PSQI was highest in the periodontitis group as compared to other two groups and the difference among three groups was statistically significant. CONCLUSION: The present study with preliminary results suggestive of the association of sleep deprivation with severity of periodontal disease, definitely calls on for future studies with larger samples.

Comparative evaluation of gingival trauma by Prophy-Jet and rubber-cup polishing techniques using aluminium trihydroxide.

OBJECTIVE: The aim of the present study was to compare the gingival trauma with Prophy-Jet and rubber-cup polishing techniques using aluminium trihydroxide as polishing agent. MATERIALS AND METHODS: 15 subjects suffering from gingivitis were enrolled in a randomized controlled split mouth experimental investigation. After scaling, Prophy-Jet and rubber-cup polishing techniques were applied on either side of the mouth using aluminium trihydroxide as polishing agent and the gingival trauma was assessed immediately after, 7 days and 21 days posttreatment using trauma index (TI). RESULTS: Statistically significant difference was observed in the mean TI scores of gingiva immediately after polishing with the two techniques, with the mean score of 0.25 ± 0.12 after rubber-cup and 0.40 ± 0.11 after prophy- jet polishing technique. CONCLUSION: Within the limitations of the study, it can be concluded that inspite of higher gingival trauma immediately after air polishing using aluminium trihydroxide agent, there was no lasting difference in gingival trauma between rubber-cup and air-polishing techniques at 7 and 21 days posttreatment.

Effect of tear osmolarity on repeatability of keratometry for cataract surgery planning.

PURPOSE: To evaluate the effects of tear osmolarity on the repeatability of keratometry (K) measurements in patients presenting for cataract surgery. SETTING: Three clinical practices. DESIGN: Observational prospective nonrandomized study. METHODS: Subjects were prospectively recruited based on tear osmolarity (Tearlab Osmolarity System); that is, osmolarity more than 316 mOsm/L in at least 1 eye (hyperosmolar) and osmolarity less than 308 mOsm/L in both eyes (normal). The baseline K value was measured, and a second measurement was taken on the same instrument (IOLMaster) within 3 weeks of the first. Variability in average K, calculated corneal astigmatism using vector analysis, and intraocular lens (IOL) sphere power calculations were compared between groups. RESULTS: The hyperosmolar group (50 subjects) had a statistically significantly higher variability in the average K reading (P = .05) than the normal group (25 subjects) and a statistically significantly higher percentage of eyes with a 1.0 diopter (D) or greater difference in the measured corneal astigmatism (P = .02). A statistically significantly higher percentage of eyes in the hyperosmolar group had an IOL power difference of more than 0.5 D (P = .02). No statistically significant differences were present when the subjects were grouped by self-reported dry eye. CONCLUSIONS: Significantly more variability in average K and anterior corneal astigmatism was observed in the hyperosmolar group, with significant resultant differences in IOL power calculations. Variability was not significantly different when subjects were grouped by self-reported dry eye. Measurement of tear osmolarity at the time of cataract surgery planning can effectively identify patients with a higher likelihood of high unexpected refractive error resulting from inaccurate keratometry. FINANCIAL DISCLOSURE: Drs. Epitropoulos, Matossian, Berdy, and Malhotra received compensation from Tearlab for participating in the study. No author has a financial or proprietary interest in any material or method mentioned.

Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: Integrated results from 2 pivotal phase 3 studies.

PURPOSE: To evaluate the efficacy and safety of phenylephrine 1.0%-ketorolac 0.3% (Omidria) for maintenance of mydriasis during, and reduction of ocular pain after, cataract surgery. SETTING: Twenty centers in the United States and the Netherlands. DESIGN: Prospective randomized clinical trials. METHODS: Patients having cataract surgery or refractive lens exchange were enrolled in 2 clinical trials. Phenylephrine 1.0%-ketorolac 0.3% or placebo was added to irrigation solution and administered intracamerally during the procedure. Integrated analyses of primary and secondary endpoints were conducted. RESULTS: The clinical trials comprised 808 patients (403 treatment and 405 placebo). Phenylephrine 1.0%-ketorolac 0.3% was superior to placebo for the maintenance of mydriasis during, and reduction of ocular pain following, cataract surgery. The mean area under the curve (AUC) change from baseline in pupil diameter was 0.08 mm for treatment compared with -0.50 mm for placebo (P < .0001). The mean AUC of ocular pain visual analog scale scores within 12 hours postoperatively was 4.16 mm for the treatment group and 9.06 mm for the placebo group (P < .001). Results of all secondary efficacy analyses demonstrated a significant treatment effect associated with phenylephrine 1.0%-ketorolac 0.3%. Treatment-emergent adverse events were as expected for a population having cataract surgery; no clinically significant differences in safety measures were observed between treatment groups. CONCLUSION: In this integrated analysis, phenylephrine 1.0%-ketorolac 0.3% administered intracamerally with irrigation solution during cataract surgery was safe and effective for maintaining mydriasis during the procedure and reducing postoperative ocular pain. FINANCIAL DISCLOSURE: Dr. Schaaf is an employee and holds an equity interest in Omeros Corporation. Drs. Hovanesian, Sheppard, Trattler, Gayton, and Ng are consultants to Omeros Corporation. No other author has a financial or proprietary interest in any material or method mentioned.

Epigenetics and periodontal disease: hope to tame the untameable.

Epigenetics means gene expression alterations which occur due to the biochemical changes of the nucleotides modifying structure of DNA rather than the changes in the genetic code itself as in case of mutations. The epigenome, consisting of chromatin and its modifications, acts as a link between the inherited genome and the changes imposed by the environment. Over the past decade, there has been mounting evidence suggestive of associations between epigenetic modifications and various human conditions such as aging, and most common human diseases viz. cancer, cardiovascular diseases, diabetes, rheumatoid arthritis, HIV etc and the clearest evidence as the central mechanism for common multifactorial diseases, has been identified with the factors involved in the inflammatory response. Periodontal disease, basically an immune-inflammatory affliction, being a multifactorial complex disease, owing to its high prevalence, chronicity and wide ranging systemic effects, essentially calls for a better comprehension of the underlying disease mechanisms, so as to develop and decipher the novel methodologies to combat this disease. The current paper aims to visualize periodontal disease from an epigenetic perspective, featuring the contemporary evidence supported literature and tends to explore the possibilities to find some explanations for perio-systemic health links, individualized and improvised diagnostic tools for earlier detection and ways to halt the disease and help regeneration and reconstruction of the lost periodontal attachment apparatus with the biology based approaches.