Improved Signs and Symptoms of Dry Eye Disease for Restasis® Patients Following a Single Tearcare® Treatment: Phase 2 of the SAHARA Study.

Purpose: To evaluate dry eye disease (DED) signs and symptoms six months after a single treatment with Localized Heat Therapy (LHT) (TearCare, Sight Sciences) for patients previously treated for six months with cyclosporine (0.05%) ophthalmic emulsion (CsA) BID (Restasis, Allergan). Setting: Nineteen ophthalmic and optometric practices in 11 US states. Design: Multicenter, cross-over, six month extension to the SAHARA randomized, controlled trial (RCT). Included patients were those randomized to CsA in Phase 1 of the SAHARA RCT. Methods: This was the second phase of the SAHARA RCT in which, following the 6-month endpoint, all patients that had been randomized to CsA discontinued CsA and were treated with LHT and subsequently followed for an additional six months. Outcome measures at 12 months for CsA patients crossed over to LHT included TBUT, OSDI and MGSS. Results: One hundred and sixty-one patients (322 eyes) were analyzed. Mean (SD) baseline TBUT prior to CsA was 4.4 (1.2) seconds, 5.6 (2.6) at 6 months which improved to 6.6 (3.2) and 6.1 (2.8) seconds (both P < 0.001) at 9 and 12 months (3, 6 months post LHT). Mean (SD) OSDI was 50.0 (14.9) at baseline and 34.2 (21.5) after CsA. With LHT at 6 months, this improved to 30.0 (20.6) and 31.0 (19.5) at 9 and 12 months (P = 0.162 vs month 6, P < 0.0001 vs baseline). MGSS was 7.1 (3.2) at baseline, 13.3 (8.2) at the end of CsA treatment which improved to 17.4 (8.8) and 16.1 (9.0) at 9 and 12 months; both P <0.001. Conclusion: SAHARA showed 6-month superiority of LHT to CsA in clinical signs and non-inferiority in symptom scores. This extension shows that patients treated with CsA for 6 months can achieve meaningful additional improvement in signs and symptoms lasting for as long as 6 months following a single LHT treatment without the need for topical prescription therapy.

A Randomized, Controlled Trial Comparing Tearcare® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA).

Purpose: We compare outcomes in eyes with dry eye disease (DED) treated with TearCare (TC) or topical cyclosporine 0.05% (RESTASIS; CsA). Setting: Nineteen ophthalmic and optometric practices in 11 US states. Design: Multicenter, randomized, assessor-masked, controlled IRB-approved trial. Eligible subjects: ≥22 years of age, dry eye symptoms within 3-6 months, Tear Break-up Time (TBUT) ≥1 to ≤7 s, Meibomian Gland Secretion Score (MGSS) ≤12, Ocular Surface Disease Index (OSDI) of 23-79. Randomized (1:1) to TC or CsA. TC subjects treated at baseline and month 5; CsA was twice daily for 6 months. Methods: Follow-up visits were scheduled for Day 1, Week 1, Months 1, 3, and 6 with primary inference at Month 6. Primary outcomes: TBUT and OSDI; secondary outcomes: MGSS, conjunctival and corneal staining, eye dryness score (EDS), symptoms assessment in dry eye (SANDE) score, and Schirmer tear score (STS). Safety assessments included adverse events, best corrected visual acuity, intraocular pressure, and slit-lamp findings. Results: Overall, 345 subjects, 172 TC and 173 CsA. TBUT improved at all time points in both groups (p<0.0001), with statistically greater improvement for TC versus CsA (p=0.0006). OSDI improved significantly at all time points in both groups (p<0.0001) with no significant differences between treatments. MGSS and other measures of meibomian gland function improved significantly more with TC eyes versus CsA; other secondary outcomes showed significant improvements in both groups with no difference between groups. Treatment-related adverse events were uncommon (10 total, 8 in the CsA group consistent with prior CsA studies); most (9/10) mild. Conclusion: TC provides statistically superior and sustained improvement in TBUT and multiple measures of meibomian gland secretion, and non-inferior improvement in OSDI, corneal and conjunctival staining, SANDE, EDS, and STS versus CsA. TC should be a preferred treatment for DED associated with MGD.

A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease.

Purpose: To compare TearCare and Lipiflow systems in the ability to reduce the symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD). Methods: In this multicenter, masked, randomized-controlled trial, 235 subjects received a single TearCare treatment (n = 115) or a single LipiFlow treatment (n = 120) and were followed for 1-month post-treatment. DED symptoms were assessed using the Ocular Surface Disease Index (OSDI), Symptom Assessment in Dry Eye (SANDE), and Eye Dryness (ED) questionnaires at baseline and at 1 month. Post-hoc subgroup analysis was conducted on subjects with less severe and more severe gland obstruction determined by baseline meibomian gland secretion score (MGSS). Results: TearCare system significantly improved total OSDI, SANDE, and ED scores from baseline (p < 0.0001) at 1-month follow-up. Subjects with more severe disease (MGSS <7) achieved statistically greater reduction with TearCare compared to LipiFlow in total OSDI score (30.4 ± 2.53 and 21.9 ± 2.37, respectively, p ANCOVA = 0.0160), OSDI Section B score for quality of vision (5.1 ± 0.48 and 3.6 ± 0.45, respectively, p ANCOVA= 0.0206), and SANDE frequency score (51.9 ± 3.70 and 41.5 ± 3.45, respectively, p ANCOVA = 0.0455). Conclusion: TearCare provides significant DED symptom relief at 1 month after a single treatment. Outcomes were consistent in OSDI, SANDE, and ED assessments. In subjects with more severe gland dysfunction, TearCare performed significantly better than LipiFlow in improving quality of vision and overall DED symptom frequency determined by OSDI and SANDE. Clinical Trial Registration Number: NCT03857919.

Comparison of the iLUX and the LipiFlow for the Treatment of Meibomian Gland Dysfunction and Symptoms: A Randomized Clinical Trial.

PURPOSE: To compare the effects of eyelid treatment with the iLUX MGD Treatment System and the LipiFlow Thermal Pulsation System on objective and subjective parameters of meibomian gland function and symptoms. PATIENTS AND METHODS: In this randomized, open-label, controlled, multicenter clinical trial, both eyes of 142 patients aged ≥18 years with Ocular Surface Disease Index (OSDI) scores ≥23, total meibomian gland scores (MGS) ≤12 in the lower eyelid of each eye, and tear break-up time (TBUT) <10 s were randomized 1:1 to iLUX or LipiFlow treatment, with stratification by test center. The primary effectiveness endpoints were changes in total MGS (masked) and TBUT from baseline to 4 weeks. The secondary effectiveness endpoint was changed in OSDI score from baseline to 4 weeks. RESULTS: Both devices significantly improved effectiveness outcomes, with no differences between the two devices. At the 4-week visit, mean MGS, TBUT, and OSDI scores improved at least 16.9 ± 11.5, 2.6 ± 3.2 s, and 28.0 ± 22.8, respectively, across treatment groups and treated eyes. Four device/procedure-related events occurred in the iLUX group, compared with none in the LipiFlow group, but there were no device-related adverse events that involved changes in lid margins, eyelids, or lash integrity. Corneal staining, intraocular pressure, and visual acuity did not differ in the two groups. CONCLUSION: Both treatments produced significant improvements in meibomian gland function and symptoms. For all effectiveness measures, there were no statistically significant differences between the two treatments.

Latanoprostene bunod ophthalmic solution 0.024%: a new treatment option for open-angle glaucoma and ocular hypertension.

Latanoprostene bunod (LBN) ophthalmic solution 0.024% is a novel, once-daily, nitric oxide-donating prostaglandin analogue for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. The IOP-lowering actions of LBN are mediated by dual mechanisms of the molecule for increasing aqueous humour outflow. The prostaglandin analogue moiety (latanoprost acid) increases uveoscleral outflow, whereas nitric oxide, released by the nitric oxide-donating moiety (butanediol mononitrate), increases outflow through the trabecular meshwork and the Schlemm's canal. The clinical efficacy and safety of LBN 0.024% in patients with open-angle glaucoma or ocular hypertension were established in two similarly designed, double-masked, pivotal phase 3 studies, APOLLO and LUNAR, the pooled three-month efficacy phase of which demonstrated significantly greater IOP-lowering of once-daily LBN 0.024% over twice-daily timolol 0.5% at all time points. Additional support for the IOP-lowering effects of LBN 0.024% was provided by two phase 2 studies in patients with open-angle glaucoma or ocular hypertension (a dose ranging study versus latanoprost and a 24-hour IOP crossover study versus timolol) and a phase 1 study of healthy volunteers with IOP in the normal range. In addition, long-term efficacy and safety were demonstrated in the open-label safety-extension phases of the phase 3 pivotal studies and a phase 3 52-week open-label study of patients with open-angle glaucoma (including normal-tension glaucoma) or ocular hypertension. In conclusion, LBN 0.024% has demonstrated both short-term and long-term IOP-lowering efficacy in patients with open-angle glaucoma or ocular hypertension, including in healthy volunteers and patients with IOP in the normal range, without apparent clinically-limiting safety or tolerability concerns.

Dual-Polymer Drops, Contact Lens Comfort, and Lid Wiper Epitheliopathy.

PURPOSE: This study compared a new contact lens rewetting drop containing both carboxymethylcellulose and hyaluronic acid (CMC-HA) with a standard drop containing carboxymethylcellulose only (CMC). Symptoms of discomfort typical in lens wear and lid wiper epitheliopathy (LWE) were assessed over a 3-month period in a diverse sample of contact lens wearers. METHODS: Adapted daily-wear contact lens subjects using hydrogel, silicone hydrogel, or rigid gas permeable lenses were enrolled in this prospective, randomized, double-masked, parallel-group, 90-day study conducted at 15 clinical sites. Subjects were randomized 2:1 to CMC-HA (n = 244) or CMC alone (n = 121) with dosage at least four times per day, along with their habitual lens care system. At baseline and at days 7, 30, 60, and 90, subject-completed questionnaires, bulbar conjunctival staining, LWE, contact lens distance visual acuity (CLDVA), and standard safety measures were assessed. RESULTS: At day 90, CMC-HA performed significantly better than CMC in ocular symptoms including dryness throughout the day (p = 0.006), and burning/stinging throughout the day (p = 0.02) and at the end of the day (p < 0.001). CMC-HA also performed numerically better for dryness at the end of day (p = 0.06). LWE staining was improved in the CMC-HA group at day 90 whereas it increased slightly in the CMC alone group, with a significant between-group difference (p = 0.009). CMC-HA also demonstrated greater reduction in conjunctival staining compared with CMC alone at day 90 (p = 0.08). No differences in CLDVA, contact lens wear time, acceptability, and product use were observed, and safety outcomes were similar between groups. CONCLUSIONS: The addition of HA to a standard CMC rewetting drop improves clinical performance. In this comparison of rewetting drop efficacy in contact lens wearers, LWE was a useful clinical sign for differentiating clinical performance.

Efficacy in patients with dry eye after treatment with a new lubricant eye drop formulation.

PURPOSE: The effective management of dry eye must include a clinically meaningful reduction in ocular staining. Evaluations of corneal and conjunctival staining and other ocular symptoms of dry eye were conducted for a new formulation of polyethylene glycol 400/propylene glycol-based lubricant eye drops containing hydroxypropyl guar as a gelling agent (Test Product) in comparison to Optive Lubricant Eye Drops (Control Product) in adult patients with dry eye. METHODS: One hundred thirteen patients, 18 years of age and older, with dry eye were enrolled in a prospective, double-masked, multisite, parallel-group study. After a 2-week run-in period during which patients administered aqueous saline eye drops 4 times daily (QID) in each eye, patients were randomized (1:1) to receive either Test Product or Control Product to be administered QID for 6 weeks. Efficacy and safety were evaluated by corneal and conjunctival staining scores, tear film breakup time, assessments of ocular symptoms, ocular surface disease index (OSDI) scores, dry eye treatment satisfaction, visual function-14 questionnaires, and adverse events. RESULTS: The intent-to-treat data set included 105 patients randomized to Test Product (n = 52) or Control Product (n = 53). Patients primarily were between the ages of 18-64 years (70.5%), female (73.3%), white (93.3%), and not Hispanic (81.9%). Patients in the Test Product group exhibited significantly lower mean corneal staining scores than the Control Product group at day 14 (P = 0.0009) and day 42 (P = 0.0106), and significantly lower mean conjunctival staining scores at day 28 (P = 0.0475) and day 42 (P = 0.0009). Patients in both treatment groups reported significant reductions in the mean scores for the ocular symptoms of dryness, gritty/sandy feeling, and burning (P

Perception and quality of life associated with the use of olopatadine 0.2% (Pataday) in patients with active allergic conjunctivitis.

This 28-d, open-label, multicenter, single-arm clinical study was designed to evaluate perceptions of olopatadine 0.2% in patients with active ocular allergic signs and symptoms. The study enrolled 330 patients, 5 to 94 y of age, who had previously used olopatadine 0.1% for active allergic conjunctivitis. Most patients were white (n=230; 70.1%) and female (n=239; 72.9%). Of all enrolled patients, 328 were evaluable for analysis. Throughout the study, patients instilled 1 drop of olopatadine 0.2% into each eye once daily; adverse events were documented and ocular evaluations were conducted to ensure patient safety. Direct evaluations of efficacy were not performed. On days 1 and 7, patients completed the Rhinoconjunctivitis Quality of Life Questionnaire, recorded their perceptions of olopatadine 0.1% (day 1) or 0.2% (day 7), and had their ocular allergies assessed globally. On each of the first 6 d of treatment, patients also completed a telephone-based perception questionnaire. On day 28, patients returned to the study center, reported their treatment perceptions, had their ocular allergies assessed, and exited the trial. Overall, patients had a positive perception of olopatadine 0.2%. Patients were more satisfied with olopatadine 0.2% than they remembered being with olopatadine 0.1% (289 vs 257 patients; 87.6% vs 77.8%; P<.05). The majority of the 48 patients who wore contact lenses (n=42; 88%) believed that they could wear their contacts as desired. Significant improvement was noted in all categories of the Rhinoconjunctivitis Quality of Life Questionnaire (P<.0001). No unexpected safety findings were reported. Patients perceived olopatadine 0.2% to be effective and well tolerated.

Clinical evaluation of an HP-guar gellable lubricant eye drop for the relief of dryness of the eye.

PURPOSE: To evaluate the efficacy of a new lubricant eye drop containing polyethylene glycol 400 and propylene glycol demulcents with hydroxypropyl-guar as a gelling agent (Test Product) to a system with carboxymethylcellulose (Control Product) for reducing dry eye signs and symptoms. METHODS: Eighty-seven dry eye volunteers were enrolled at seven sites for this six-week, concurrently controlled, double-masked clinical study. RESULTS: The Test Product significantly reduced conjunctival staining (p = 0.025) and temporal corneal staining (p = 0.024) compared to the Control. The Test Product also significantly reduced symptoms of dryness in the morning and evening, compared to the Control (p = 0.015 and p = 0.023, respectively). Subjects in the Test treatment group reported lower frequencies of foreign body sensation and felt their eyes were "refreshed longer" compared to those in the Control group (p = 0.033 and p = 0.037, respectively). CONCLUSIONS: The Test Product was more effective at reducing both the signs and symptoms of dry eye compared to the carboxymethylcellulose containing Control.

Posterior chamber phakic intraocular lens for moderate myopia and hyperopia.

BACKGROUND: As part of the United States Food and Drug Administration Phase III clinical trial, patients were implanted with the STAAR posterior chamber phakic intraocular contact lens (ICL). The trial is designed to test the safety and efficacy of this new lens for the treatment of moderate-to-high myopia and hyperopia. METHODS: Data were collected from 20 hyperopes--mean preoperative spherical equivalent, +5.55 D, and 65 myopes-mean preoperative spherical equivalent, -8.42 D, who were implanted with ICLs in our clinic, from November 1998 to March 2000. RESULTS: Postoperatively, 40% of the hyperopic eyes were 20/20 or better without correction and 80% of the eyes 20/40 or better without correction, with a mean spherical equivalent of +0.06 D. One hyperopic lens was explanted and no adverse events were reported. Postoperatively, 52.31% of the myopic eyes were 20/20 or better without correction and 92.3% of the eyes were 20/40 or better without correction, with a mean spherical equivalent of -0.31 D. No lenses were explanted and one was treated for angle closure. CONCLUSIONS: The STAAR Collamer ICL is a reasonably safe and effective procedure for the treatment of moderate-to-high refractive errors.