Pilocarpine HCl 1.25% for treatment of presbyopia after laser vision correction: pooled analysis of two phase 3 randomized trials (GEMINI 1 and 2).

PURPOSE: To evaluate the efficacy of topical pilocarpine HCl 1.25% (Pilo) in treating presbyopia in individuals with or without a history of laser vision correction (laser-assisted in situ keratomileusis [LASIK] or photorefractive keratectomy [PRK]). SETTING: Multiple clinical sites. DESIGN: Pooled analysis of 2 identically designed prospective, randomized, vehicle-controlled studies (GEMINI 1 and 2). METHODS: Adults aged 40 to 55 years with presbyopia received once-daily Pilo or vehicle bilaterally for 30 days. Responder rates for ≥3-line improvement in mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA) were determined on day 30. RESULTS: Among participants with a history of LASIK/PRK (n = 39 in the Pilo group, n = 41 in the vehicle group), responder rates for ≥3-line improvement in DCNVA on day 30 at hours 0.25, 0.5, 1, 3, 6, 8, and 10, respectively, were 16.7%, 38.9%, 41.7%, 37.8%, 16.2%, 13.9%, and 8.3% with Pilo and 0.0%, 2.6%, 10.5%, 5.1%, 7.7%, 2.6%, and 0.0% with vehicle. Responder rates in the LASIK/PRK subgroup were significantly higher with Pilo than vehicle at hours 0.25 ( P = .0087), 0.5 ( P = .0001), 1 ( P = .0022), and 3 ( P = .0005). In contrast, there were no significant differences in responder rates between Pilo-treated participants with and without LASIK/PRK. Among non-LASIK/PRK participants in the Pilo group (n = 336), responder rates for ≥3-line improvement in DCNVA on day 30 at hours 0.25, 0.5, 1, 3, 6, 8, and 10, respectively, were 16.8%, 32.7%, 39.0%, 28.0%, 17.4%, 12.6%, and 10.5%. CONCLUSIONS: Pilo treatment effectively and similarly improved DCNVA in presbyopes with or without a history of laser vision correction.

Development and validation of a new photographic scale to grade lid wiper epitheliopathy.

PURPOSE: Lid wiper epitheliopathy (LWE) is a clinical sign that has been associated with dry eye disease (DED) and contact lens discomfort (CLD). This study describes the development, validation and graders' preference of a new photographic scale for LWE, the Photographic Lid Wiper Epitheliopathy (PLWE) scale. METHODS: The PLWE grading scale was developed using LWE images selected from 57 screened patients (≥18 years of age) with confirmed LWE in both eyes. To validate the PLWE scale, a set including 20 images showing varying degrees of LWE from none to severe was chosen. To assess grading validity and grading reliability, observers were asked to grade the selected images using the PLWE and another commonly used subjective LWE grading protocol (Korb) on two separate sessions. RESULTS: The mean grade (±SD) of all images was not statistically significant different between the PLWE scale (1.55 ± 0.44) and the alternative grading scale (Korb, 1.47 ± 0.54) (ANOVA F1, p > 0.05). The average difference from the mean of all graders was 0.03 ± 0.53 using the PLWE scale and 0.06 ± 0.57 when using the Korb protocol (ANOVA F1, p > 0.05). The Coefficient of Repeatability was 1.04 and 1.12 for the PLWE and Korb scales (p > 0.05). Ninety-five percent of the graders found PLWE easier to use than Korb and the same percentage would consider using the PLWE scale in clinical practice. CONCLUSION: The format of the PLWE is similar to other anterior segment visual grading scales and this study revealed an ease of use preference for employing the PLWE by the graders. The presence of LWE has been associated with DED and CLD, and the addition of this new photographic scale could facilitate clinical judgement and record keeping of LWE in clinical practice.

Tribology and the Ocular Surface.

Introduction: Tribology is known as the science of friction, lubrication and the determination of what occurs when two surfaces slide against one another. The required partners in this science are a minimum of two surfaces and relative motion. Tribology could be a key factor in dissecting the issues that surround and confound dry eye in patients as well as contact lens discomfort and intolerance. Specifically, it is this issue that is a potential causative underlying factor that could lead to conditions like lid wiper epitheliopathy (LWE). Methods: Peer-reviewed literature was reviewed as It pertains to ocular tribology and the application to the ocular anatomy. A PubMed review was performed using the keywords: tribology, friction, lid wiper epitheliopathy, contact lens, and dry eye. All manuscripts were reviewed for mentions of tribology and friction. The exact same process was performed with The Association for Research in Vision and Ophthalmology (ARVO) abstracts. Results: In relation to the ocular surface, tribology describes the mechanical interactions between the upper and lower lid wipers and the globe. The Stribeck curve can be applied, as the sliding partners are separated by a complex, lubricating tear film. The surface brush anatomy at the eye to eyelid juncture reduces friction and alters the Stribeck curve in favor of the hydrodynamic regime, allowing for high velocity movement with minimal wear. Changes to the tear film or the introduction of a contact lens can displace the Stribeck curve, increase friction, and induce wear thus leading to patient symptomology. Conclusion: Further studies may provide new insight into contact lens discomfort and ocular surface disease, including LWE; however, adaptation of tribology work performed in vitro to in vivo patient care is challenging.

Natural course of lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers.

PURPOSE: To establish the time course of lid wiper epitheliopathy (LWE) in established CL wearers after a single day (6-10 h) of daily disposable contact lens (CL) wear, the following day post-CL removal and 1-week after CL discontinuation. METHODS: Twenty-one symptomatic (CLDEQ-8 score ≥ 12) habitual wearers of MyDay® silicone hydrogel daily disposable were included. LWE staining was assessed prior to CL wear (Visit 1, V1) using semi-automated analysis after instillation of two drops of 1 % lissamine green (10 µL) that were applied to the superior bulbar conjunctiva. LWE measurements were repeated after 6-10 h of continuous CL wear (Visit 2, V2), post-CL removal the following day (Visit 3, V3) and after 1-week CL discontinuation (Visit 4, V4). At each visit, ocular symptoms were evaluated using the SPEED-8 questionnaire and set of 0-100 visual analogue scales (VAS). RESULTS: LWE showed no significant changes after 6-10 h of continuous CL wear (p = 0.536), post-CL removal the following day (p = 0.677) or following 1-week of CL discontinuation (p = 0.478). Analysis revealed a significant improvement in symptomatology between V1 and V2 (SPEED-8, p < 0.01) and also improvements in the 0-100 VAS scores between V2 and V4 for average daily dryness (p < 0.01), end-of-day dryness (p < 0.01) and frequency of end-of-day dryness (p < 0.05). CONCLUSION: The present data suggest that the etiology of LWE is multifactorial and the sole intervention of temporarily discontinuing CL wear does not lead to resolution of these clinical signs.

Optimal methodology for lid wiper epitheliopathy identification.

PURPOSE: Lid wiper epitheliopathy (LWE) is a clinical sign that has been associated with dry eye disease. This study used a semi-automated method to identify the effect of drop instillation and post-dye viewing time on the absorption of lissamine green (LG) and sodium fluorescein (NaFl) on the upper eyelid in order to ascertain the optimal identification for LWE assessment. METHODS: In 37 participants with LWE, 1-drop of 1% LG (10 µL) was applied to the superior bulbar conjunctiva in the right eye, and photographs of the lid margin were taken 1, 3, and 5 min after instillation. Measurements were repeated in the same eye following instillations of 2-drops of 1% LG. The same procedures were followed for application of 2% NaFl (2 µL) to the left eye. Staining area was determined using software to detect and measure dye-stained images. Analysis used a linear mixed model with fixed effects of time, number of drops and their interaction. RESULTS: For LG, multivariate analysis showed that time of drop instillation was significant (p = 0.0091) as was the area of staining in the 2-drop versus 1-drop condition (p < 0.0001). For NaFl, there was a significant effect of time (p < 0.0001), drops (p < 0.0001), and a time/drops interaction (p < 0.0134), suggesting that both time and number of drops are important. CONCLUSION: A single drop of dye is insufficient to reveal the full extent of LWE staining. A 2-drop instillation is recommended and observation is recommended between 1 and 5 min (LG) and between 3 and 5 min (NaFl).