Status:
TERMINATED
Lid Wiper Epitheliopathy Trial
Lead Sponsor:
Alcon Research
Conditions:
Lid Wiper Epitheliopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT01870856
Start Date
July 1 2013
End Date
October 1 2013
Last Update
October 29 2014
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