Lid Wiper Epitheliopathy Trial

Alcon

Status: Terminated

Conditions: Lid Wiper Epitheliopathy

Treatments: Device: Spectacles; Device: Etafilcon A contact lenses; Device: Delefilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01870856

C-13-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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187 participants in 4 patient groups

Spectacles, Stage 1

Experimental group

Description:

Spectacles per participant's habitual perscription worn for 2 weeks

Treatment:

Device: Spectacles

1-DAY ACUVUE, Stage 1

Active Comparator group

Description:

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

Treatment:

Device: Etafilcon A contact lenses

DAILIES TOTAL1, Stage 2

Experimental group

Description:

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

Treatment:

Device: Delefilcon A contact lenses

1-DAY ACUVUE, Stage 2

Active Comparator group

Description:

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

Treatment:

Device: Etafilcon A contact lenses