Formula Identification (FID) 114657 in Contact Lens Wearers

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Drug: Saline control eye drops (15 ml); Drug: FID 114657 eye drops (10 ml); Device: Habitual contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02293538

LCO242-P001

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

234 participants in 2 patient groups

FID 114657

Experimental group

Description:

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.

Treatment:

Device: Habitual contact lenses

Drug: FID 114657 eye drops (10 ml)

Saline Control

Active Comparator group

Description:

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.

Treatment:

Drug: Saline control eye drops (15 ml)

Device: Habitual contact lenses