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

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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.


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.
We found this trial at
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