Lid Wiper Epitheliopathy Trial

Not Applicable

Terminated

• Conditions: Lid Wiper Epitheliopathy
• Interventions: Device: Etafilcon A contact lenses; Device: Spectacles; Device: Delefilcon A contact lenses

• Registration Number: NCT01870856
• Lead Sponsor: Alcon Research

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-06
• Study Start: 2013-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Results First Submitted: 2014-10-24
• Results First Submitted QC: 2014-10-28
• Last Update Submitted: 2014-10-28
• Results First Posted: 2014-10-29
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 187

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-DAY ACUVUE, Stage 2	Etafilcon A contact lenses	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
Spectacles, Stage 1	Spectacles	Spectacles per participant's habitual perscription worn for 2 weeks
DAILIES TOTAL1, Stage 2	Delefilcon A contact lenses	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
1-DAY ACUVUE, Stage 1	Etafilcon A contact lenses	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

Primary Outcome Measures

Name	Time	Method
Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks	Baseline, Week 2	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.
Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks	Baseline, Week 2	This outcome measure was not evaluated since primary efficacy was not demonstrated.

Secondary Outcome Measures

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