Lid Wiper Epitheliopathy Trial

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

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.

Study Overview

• Status: Terminated
• Conditions: Lid Wiper Epitheliopathy
• Intervention / Treatment: Device: Spectacles; Device: Etafilcon A contact lenses; Device: Delefilcon A contact lenses

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 Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Spectacles, Stage 1; Spectacles per participant's habitual perscription worn for 2 weeks	Device: Spectacles; Per participant's habitual prescription
ACTIVE_COMPARATOR: 1-DAY ACUVUE, Stage 1; 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; Hydrogel single vision contact lenses; Other Names: 1-DAY ACUVUE®
EXPERIMENTAL: DAILIES TOTAL1, Stage 2; 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; Silicone hydrogel single vision contact lenses; Other Names: DAILIES TOTAL1®
ACTIVE_COMPARATOR: 1-DAY ACUVUE, Stage 2; 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; Hydrogel single vision contact lenses; Other Names: 1-DAY ACUVUE®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Anne Brobst, OD, FAAO, Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (ESTIMATE): June 6, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Myopia; Contact lenses; Ocular discomfort
• Other Study ID Numbers: C-13-005