Lid Wiper Epitheliopathy Trial

NCT ID: NCT01870856

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-10-31

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.

Conditions

Lid Wiper Epitheliopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Spectacles, Stage 1

Spectacles per participant's habitual perscription worn for 2 weeks

Group Type: EXPERIMENTAL

Spectacles

Intervention Type: DEVICE

Per participant's habitual prescription

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

Group Type: ACTIVE_COMPARATOR

Etafilcon A contact lenses

Intervention Type: DEVICE

Hydrogel single vision contact lenses

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

Group Type: EXPERIMENTAL

Delefilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel single vision contact lenses

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

Group Type: ACTIVE_COMPARATOR

Etafilcon A contact lenses

Intervention Type: DEVICE

Hydrogel single vision contact lenses

Interventions

Spectacles

Per participant's habitual prescription

Intervention Type: DEVICE

Delefilcon A contact lenses

Silicone hydrogel single vision contact lenses

Intervention Type: DEVICE

Etafilcon A contact lenses

Hydrogel single vision contact lenses

Intervention Type: DEVICE

Other Intervention Names

DAILIES TOTAL1®; 1-DAY ACUVUE®

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Brobst, OD, FAAO

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-13-005

Identifier Type: -

Identifier Source: org_study_id