Status:
COMPLETED
Formula Identification (FID) 114657 in Contact Lens Wearers
Lead Sponsor:
Alcon Research
Conditions:
Refractive Error
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.
Eligibility Criteria
Inclusion
- Must sign the informed consent form.
- Stable, tear lipid layer thickness ≤ 75 nm without contact lenses.
- Successfully wearing bi-weekly or monthly replacement soft contact lenses in both eyes for a minimum of 5 days/week during the past 2 months prior to Visit 1.
- Vision correctable to 20/25 Snellen (feet) or better at distance with habitual contact lenses at Visit 1.
- Willing to wear lenses 5 days a week, 8 hours a day for at least 2 days during the study.
- Demonstrate symptoms of contact lens discomfort.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Routinely sleeping in lenses.
- Any active eye inflammation or condition that contraindicates contact lens wear.
- Any systemic diseases that could prevent successful contact lens wear.
- Use of systemic or ocular medications that contraindicate lens wear.
- Fit with only 1 contact lens.
- Unwilling to discontinue the use of cosmetics (such as eyeliner, mascara, or eye shadow) or facial creams on or around the eyelids on Day 1 and Day 14 of the study.
- Women of childbearing potential who are currently pregnant, test positive for pregnancy at Screening visit, breast feeding, or unwilling to use adequate birth control throughout the study.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT02293538
Start Date
November 1 2014
End Date
July 1 2015
Last Update
October 6 2016
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