FID# 114657 in Contact Lens Wearers
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | November 2014 |
End Date: | July 2015 |
Evaluation of a Lubricant Eye Drop on Tear Lipid Layer Thickness in Contact Lens Wearers
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.
after 2 hours of lens wear with use of FID #114657 compared to saline control.
Inclusion Criteria:
- Must sign the informed consent form.
- 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.
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