Patient-Reported Wearing Experience From Hydrogel Daily Disposable Wearers Older Than 40 Years From the TEMPO Registry.

OBJECTIVES: To describe the patient-reported wearing experience over time among wearers of hydrogel daily disposable (HydDD) contact lenses (CLs) in the TruEye and Moist Performance Overview (TEMPO) Registry (NCT01467557). METHODS: Registered wearers older than 40 years who were recently fit with 1-DAY ACUVUE MOIST HydDDs completed self-administered questionnaires four times during a year-long Registry. Overall opinion of CLs, replacement schedules, Contact Lens Dry Eye Questionnaire (CLDEQ-8), and compliance were queried. Data were analyzed with analysis of variance and signed rank tests. RESULTS: A total of 86 subjects (24% men, age 50.2±7.1 years) completed the Registry. Approximately 76% were new to daily disposable lenses, and 8% were neophytes. Overall opinion of CLs improved significantly after refitting with HydDDs (baseline 57% excellent/very good vs. 69%-79% at follow-ups, P<0.05 all vs. baseline). Changing to HydDDs maintained average and comfortable wear time (P>0.05), and it did significantly improve CLDEQ-8 scores at all follow-ups (baseline, 11.2±7.3 vs. 2 weeks, 7.8±5.8, P<0.0001; 4 months, 8.6±6.5, P=0.0006; 12 months, 9.3±6.5, P=0.01). Self-assessment of compliance was excellent/very good for 80% at baseline, and improved to 92% to 98% at follow-ups (P<0.0001). More than 90% never slept in their HydDDs, although compliance to daily replacement diminished from 2-week to 4-month surveys (93% vs. 84%, P=0.007). CONCLUSIONS: After refitting with HydDDs, older wearers reported significantly higher overall opinions of their lenses, better CLDEQ-8 symptom scores, and most were compliant with proper daily disposable lens use. Diminishing daily replacement rates from 2 weeks to 4 months indicate a need to reinforce that recommendation. Wearers of HydDD CLs older than 40 years experienced many benefits from refitting with these daily disposable lenses.

Cutoff score and responsiveness of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) in a Large daily disposable contact lens registry.

PURPOSE: To report (1) results of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among a large sample of SCL wearers before and during 1 year after fitting with one of 2 daily disposable (DD) lenses (etafilcon A or narafilcon B) in the TEMPO Registry, (2) the cut-off score to identify highly symptomatic SCL wearers and (3) the clinically important difference (CID) in the CLDEQ-8 score. METHODS: Demographics, CL history and patterns of SCL use were documented. Construct validity of the CLDEQ-8 was tested versus overall opinion (OO) of habitual SCLs, eye dryness and eye sensitivity at baseline. Responsiveness to change in OO was tested. Cutoff score, CID, and predictive accuracy were analyzed with general linear mixed models, adjusting for clustering by site with Bonferoni correction for multiple comparisons. RESULTS: Baseline CLDEQ-8 data from 977 habitual SCL wearers showed significant association with OO, eye dryness and sensitivity (p<0.0001, all). CLDEQ-8 scores improved significantly after refitting and reflected change in OO over time (p<0.0001). Diagnostic cutoff of≥12 and CID of 3 points performed best. CONCLUSIONS: The CLDEQ-8 score of ≥12 points is proposed to identify SCL wearers who could benefit from clinical management of their CL-related symptoms. The clinically important difference was ±3 points. Refitting to these DD lenses in the TEMPO Registry provided significant and stable reduction in SCL-related symptoms across the year of follow-up. Use of the CLDEQ-8 in clinical practice and clinical research will help quantify and standardize symptom measures in SCL wearers.

Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry.

PURPOSE: To report annualized adverse events (AEs) including corneal infiltrative events (CIEs) with use of silicone hydrogel (SiHyDD) and hydrogel daily disposable (HydDD) soft contact lenses (SCLs) in the 1•DAY ACUVUE TruEye or 1•DAY ACUVUE MOIST Performance Overview (TEMPO) Registry (NCT01467557). METHODS: Annualized incidence of symptomatic daily disposable (DD)-related AEs was calculated from 3064 surveys from 1171 subjects (601 SiHyDD and 570 HydDD, 31.8 ± 13.5 years, 68% female) during 1 year. Three independent experts adjudicated potential AE cases. Demographics were compared between wearers with and without AEs. RESULTS: The registry tracked 960.3 years of lens wear: SiHyDD 489.4 years and HydDD 470.9 years. In that period, the 601 SiHyDD wearers reported eight AEs with office visits (1.6%/y; 2 CIEs, 0.4%/y), eight (1.6%/y) without office visits, and four AEs unrelated to SCLs (0.8%/y) (SiHyDD wearers with AEs; 44.8 ± 12.5 years; 75% female). The 570 HyDD wearers reported three AEs with office visits (0.6%/y; no CIEs), five without office visits (1.1%/y), and one non-SCL-related AE (0.2%/y) (HydDD wearers with AEs; 26.3 ± 8.0 years; 100% female). These CIE rates are significantly lower than the lowest estimate of 3.3% from prior studies. Wearers with SiHyDD-related AEs were significantly older than unaffected wearers (P = 0.02), but not for HydDD-related AEs. CONCLUSIONS: The CIE rates of 0.4% and 0% with these DD lenses are significantly lower than rates reported with reusable SCLs (3%-4%/y), indicating improved safety outcomes with these DD lenses. Compared to unaffected wearers, SiHyDD lens wearers with AEs requiring clinical visits were significantly older. (ClinicalTrials.gov number, NCT01467557.).

Application of senofilcon a contact lenses for therapeutic bandage lens indications.

PURPOSE: To conduct a retrospective consecutive chart review of senofilcon A contact lenses when used for therapeutic or bandage lens applications. Indication for use includes corneal protection from exposure or repeated irritation, corneal pain relief, and barrier protection. Outcome assessments included pain relief, improvement in corneal signs, additional complications, and overall treatment success. METHODS: A total of 43 fully consented patients across 3 different clinical practices in the United States (Georgia, Florida and Ohio) were included in this study. Subjects enrolled in the study were identified by site investigators as their most recent 15 to 20 patients fit in senofilcon A lenses for the listed therapeutic indications. The cases were reviewed to assess the therapeutic success of the lens for the outcomes listed earlier. RESULTS: All lenses fit had an 8.4-mm base curve and 14.0 mm diameter. Patients were fit for pain relief in 26 of the 43 cases of which 81% were judged to be fully effective, 8% partially effective, and 11% ineffective. Improvement in corneal integrity was the treatment goal in 25 cases and was fully effective in 64%, partially effective in 24%, and no change was noted in 12% of the cases. Twelve refractive surgical patients (laser-assisted in situ keratomileusis, epithelial laser-assisted in situ keratomileusis, laser-assisted subepithelial keratectomy, or photorefractive keratectomy) wore the lenses successfully for 4 to 6 days postoperatively for comfort and protection without complications. Investigators judged the overall treatment as fully successful in 68% cases, partially successful in 18% cases, and neutral or unsuccessful in 14% cases. No adverse events were reported in any case. CONCLUSIONS: Senofilcon A contact lenses are successful in the majority of cases when used for providing protection of corneal exposure and recurrent damage, pain management, barrier protection, and postsurgical management.

Overview of contact lens postmarket surveillance in the United States: system and recent study results.

This is an overview of the US contact lens (CL) postmarket surveillance systems and surveillance study results that include silicone hydrogel CLs. As 30-night continuous wear silicone hydrogel and rigid gas-permeable (RGP) CLs were approved for use in the United States in 2001, the Food and Drug Administration (FDA) mandated large postmarket surveillance studies to assess the risk of microbial keratitis with those products when worn with the 30-night wearing schedule. Since the time of the approvals, RGP 30-night wear has been used sparingly and a shift from 30-night wear has occurred for silicone hydrogel lenses. Several silicone hydrogel lenses have been approved and most of these lenses are being prescribed for daily or flexible wear and not for 30-night wear. With daily wear and less overnight use, silicone hydrogel lenses are regularly exposed to lens care products, lens cases, and improper handling, all of which may introduce sources of microbial contamination that could trigger lens-related complications. This summary of CL postmarket surveillance system and methods gives results of FDA-mandated surveillance and of recent US studies that observed "real-world" populations for safety results outside the bounds of highly controlled prospective clinical trials.

Diiododurene: four centrosymmetric molecules in general positions.

Diiododurene (1,4-diodo-2,3,5,6-tetramethylbenzene), C(10)H(12)I(2), packs with four molecules in the asymmetric unit. All four of these moleules violate Kitaigorodsky's suggestion that molecules with centers of symmetry will lie on crystallographic centers of symmetry. There is 5.6% disorder at one of the sites. Most of the I atoms are in contact with other I atoms, but only six of the I.I contacts are shorter than 4.2 A. Of these six contacts, one set of three contacts forms a triangular set in which all of the I.I distances are less than 3.9 A.

A 1-year prospective clinical trial of menicon Z (tisilfocon A) rigid gas-permeable contact lenses worn on a 30-day continuous wear schedule.

PURPOSE: To establish the safety and efficacy of clinical performance of a novel hyper-O2-transmitting rigid gas-permeable (RGP) lens (tisilfocon A) worn continuously for 30 days (29 nights) equivalent to a conventional control hydrogel lens (etafilcon A) worn for 7 days (6 nights). METHODS: The study was a prospective, open-label, 24-center, concurrent cohort-controlled clinical trial. OUTCOME MEASURES: Outcome measures included rates of adverse events, slitlamp findings, length of wear achieved, lens-corrected visual acuity, corneal refractive changes, dryness, and lens deposits. RESULTS: The RGP lens wear test was equivalent or superior to the hydrogel control performance in all categories. Two-thirds (66.5%) of patients wearing the RGP lens achieved continuous wear periods greater than 22 nights; and 60.4% achieved more than 28 nights of continuous use. There was a statistically significant lower rate of adverse events, considered definitely related to lens wear, for the RGP test lens versus the hydrogel control (none vs. 2.2%; P = 0.007, Fisher's exact two-sided test). CONCLUSIONS: Continuous wear of the tisilfocon A (Menicon Z, Menicon Co., Ltd., Nagoya, Japan) RGP lens for up to 30 nights is a safe and equivalent alternative to 7-day (6-night) hydrogel wear.

Corneal thickness results in the Menicon Z 30-day continuous wear and ACUVUE 7-day extended-wear contact lens clinical trial.

PURPOSE: This study was conducted to measure the corneal thickness changes associated with wearing 30-day tisilfocon A (Dk = 163) and 6-day etafilcon A (Dk = 28) contact lenses. The probable cause of the outcomes is discussed. METHODS: Thirty subjects were fitted with Menicon Z rigid gas-permeable (RGP) contact lenses and a control group (n = 30) was fitted with ACUVUE hydrogel lenses, at two study sites. After a 2-week period of daily wear, subjects began prolonged wear. Measurements were performed at the dispensing visit, and then at the 2-week daily wear, the 1-week, 6-month, and 12-month extended- and continuous-wear visits. RESULTS: Repeated measures analysis of covariance was performed on mean corneal thickness. There was a significant increase in corneal thickness in the hydrogel lens extended-wear group compared to the RGP group (P = 0.03). The mean corneal thickness in the ACUVUE group was 2.58% higher at the 2-week daily wear visit, 2.38% higher at the 1-week extended-wear visit, 2.96% higher at the 6-month, and 2.97% higher at the 1-year visit compared to the RGP continuous-wear patients. DISCUSSION: Patients wearing high-Dk RGP contact lenses for continuous wear may have thinner corneas (within the normal thickness range) probably because of minimal hypoxia-induced corneal stromal swelling; RGP-induced reversible corneal epithelial compression; deceased epithelial sloughing; or long-term contact lens-induced keratocyte apoptosis. Patients wearing hydrogel contact lenses for extended wear may have thicker corneas because of hypoxia-induced corneal stromal swelling. Additional evidence of corneal hypoxic stress is seen in the higher prevalence of striae and epithelial microcysts in the hydrogel group and greater variability of corneal thickness measurements in the soft contact lens group in our results.

Corneal endothelial morphology results in the Menicon Z 30-day continuous-wear contact lens clinical trial.

PURPOSE: This evaluation was conducted as part of a protocol entitled Evaluation of the Menicon Z Rigid Gas Permeable Contact Lens for up to 30 Days Extended Wear. The purpose of the protocol was to compare corneal endothelial morphology changes after wearing rigid gas-permeable (RGP) Menicon Z contact lenses, continuously for up to 30 days, with ACUVUE (Johnson & Johnson Vision Care) hydrogel contact lenses, worn for up to 6 nights of extended wear. METHODS: Sixty patients, who were adapted to RGP daily wear and soft contact lens daily wear, were recruited at two study sites. The thirty subjects who wore RGP daily wear lenses were fitted with the Menicon Z (tisilfocon A, oxygen permeablility [Dk] = 163) RGP contact lens comprised the test group. The control group subjects (n = 30 former users of daily wear soft contact lenses) were fitted with ACUVUE (etafilcon A, Dk = 28) hydrogel contact lenses. After a 2-week adaptation period of daily wear, subjects began extended wear. Endothelial imaging was performed at the two study sites in this multicenter study (University Hospitals of Cleveland/Case Western Reserve University Department of Ophthalmology [CWRU] and The Ohio State University [OSU]). The hydrogel lens group was instructed to wear their lenses for 7 days and 6 nights before discarding the lenses and to sleep with no lenses on the seventh night. The RGP group was permitted to wear the lenses for up to 30 days and 29 consecutive nights before removing the lenses for cleaning and overnight soaking. RESULTS: CWRU had 24 patients (12 soft contact lens and 12 rigid contact lens) and OSU had 21 patients (12 soft contact lens and 9 rigid contact lens) who completed the study and were included in the analyses. Patients who were withdrawn from the study at CWRU included one RGP patient dropped out because of pregnancy; one RGP patient developed vascularized limbal keratitis and discomfort; one could not be fitted with a bitoric RGP; two soft lens patients moved from the area, and one dropped out because of dry eyes. At OSU, four patients dropped out due to discomfort (two in each lens type);one moved from the study area; one decided not to participate soon after the consent visit; one had worries of reduced vision at 6 months; one subject's attitude changed prior to the 6 month visit; and one subject was withdrawn for reasons of poor study schedule compliance. CONCLUSION: The Menicon Z lens wearers in this study did not show significant endothelial cell morphology changes after 1 year of nearly continuous contact lens wear. This finding is particularly important considering the RGP wearers in this study were older by a average of 10 years (mean age approximately 40) and had worn their contact lenses an average of almost 10 years longer than the soft contact lens wearers.

Menicon Z 30-day continuous wear lenses: a clinical comparison to Acuvue 7-day extended wear lenses.

PURPOSE: To establish equivalent safety and efficacy of the clinical performance of a novel hyper-O2 transmissible rigid gas-permeable (RGP) lens (Menicon Z, tisilfocon A) when worn continuously for 30 days (29 nights) when compared with a conventional control hydrogel lens (Acuvue; etafilcon A) worn for 7 days (6 nights). METHODS: This study was a prospective, open-label, 24-center, concurrent, cohort-controlled clinical trial. This abbreviated report will focus on the length of wear achieved, slitlamp findings, and adverse event rates. RESULTS: Two-thirds (66.5%) of patients wearing the RGP lens achieved greater than or equal to 22 nights of continuous wear; slitlamp observations revealed two categories of findings: those associated with lens modality and those with lens wearing time. Adverse events were mostly associated with foreign body abrasions for RGP lenses, whereas the hydrogel lens showed a higher number of bacterial infections. CONCLUSION: The results of this study revealed some interesting differences in the classification and severity of findings. The results demonstrate that the continuous wear of Menicon Z (tisilfocon A) RGP lenses for up to 30 nights is a safe and equivalent alternative to 7-day (6 nights) hydrogel wear lenses.