Formula Identification (FID) 114657 in Contact Lens Wearers

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a Lubricant Eye Drop on Tear Lipid Layer Thickness in Contact Lens Wearers

Conditions
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Refractive Error

Intervention / Treatment
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* Drug: FID 114657 eye drops (10 ml)
* Drug: Saline control eye drops (15 ml)
* Device: Habitual contact lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 114657<br>FID 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. | Drug: FID 114657 eye drops (10 ml)<br>* Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye<br>Device: Habitual contact lenses<br>* Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power<br>|
| Active Comparator: Saline Control<br>Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. | Drug: Saline control eye drops (15 ml)<br>* Saline eye drops (15 ml)<br>Device: Habitual contact lenses<br>* Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1 | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure. | Day 1, after 2 hours of lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14 | At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. The participant rated both eyes together by providing one single rating. This outcome measure was prespecified for only FID 114657. | Baseline (Day 0), Day 14 | 
| Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses | Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen. A 1-unit increase indicates improvement. The participant rated both eyes together by providing one single rating. | Baseline (Day 0), Day 14 | 
| Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14 | At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. A positive change from Baseline indicates improvement. The participant rated both eyes together by providing one single rating. | Baseline (Day 0), Day 14 | 
| Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14 | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure. | Day 14, after 2 hours of lens wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptoms of Contact Lens Related Discomfort