Lid Wiper Epitheliopathy Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.

Detailed Description
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This study will be conducted in two stages. In Stage 1, participants will wear either spectacles or contact lenses for two weeks to determine the impact of interruption of contact lens wear on LWE. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and LWE and ocular discomfort will be compared.

Official Title
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Evaluation of Lid Wiper Epitheliopathy With and Without Daily Disposable Contact Lenses

Conditions
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Lid Wiper Epitheliopathy

Intervention / Treatment
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* Device: Spectacles
* Device: Delefilcon A contact lenses
* Device: Etafilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign Informed Consent document. Severe lid wiper epitheliopathy (upper lid) in either eye. Currently wearing spherical daily disposable soft contact lenses or daily wear soft contact lenses in both eyes with at least 3 months of contact lens wearing experience. Symptomatic as determined by the SPEED questionnaire. Willing to follow visit schedule. Habitual contact lens power with the range of -1.00 to -6.00 diopters (D) with best corrected distance visual acuity greater than or equal to 20/25 in each eye. Astigmatism less than or equal to 0.75D. Possess spectacles which provide visual acuity of at least 20/25 in each eye. Willing and able to complete daily diaries. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury within 12 weeks immediately prior to enrollment. Any ocular condition that would contraindicate contact lens wear. Any use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator. Currently wearing toric or multifocal soft contact lenses. Participation in a clinical study (including contact lens or contact lens care product) within the previous 30 days. Routinely sleeps in lenses for at least 1 night per week. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spectacles, Stage 1<br>Spectacles per participant's habitual perscription worn for 2 weeks | Device: Spectacles<br>* Per participant's habitual prescription<br>|
| Active Comparator: 1-DAY ACUVUE, Stage 1<br>Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode | Device: Etafilcon A contact lenses<br>* Hydrogel single vision contact lenses<br>* Other names: 1-DAY ACUVUE®;|
| Experimental: DAILIES TOTAL1, Stage 2<br>Delefilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode | Device: Delefilcon A contact lenses<br>* Silicone hydrogel single vision contact lenses<br>* Other names: DAILIES TOTAL1®;|
| Active Comparator: 1-DAY ACUVUE, Stage 2<br>Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode | Device: Etafilcon A contact lenses<br>* Hydrogel single vision contact lenses<br>* Other names: 1-DAY ACUVUE®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks | LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis. | Baseline, Week 2 | 
| Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks | This outcome measure was not evaluated since primary efficacy was not demonstrated. | Baseline, Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks | This outcome measure was not evaluated since primary efficacy was not demonstrated. | Baseline, Week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular discomfort, Contact lenses, Myopia