N/A
N=144
Formula Identification (FID) 114657 in Contact Lens Wearers
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT02293538 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1 — 61.2; 61.5 ICU
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FID 114657 eye drops (10 ml) (Drug); Saline control eye drops (15 ml) (Drug); Habitual contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1 |
61.2; 61.5 | — |
| SECONDARY Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14 |
7.43; 10.69 | — |
| SECONDARY Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses |
84.5; 79.4 | — |
| SECONDARY Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14 |
3.12; 3.28 | — |
| SECONDARY Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14 |
58.5; 59.4 | — |
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 Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02293538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.