Formula Identification (FID) 114657 in Contact Lens Wearers

NCT ID: NCT02293538

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-07-31

Brief 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.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

FID 114657

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.

Group Type: EXPERIMENTAL

FID 114657 eye drops (10 ml)

Intervention Type: DRUG

Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye

Habitual contact lenses

Intervention Type: DEVICE

Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power

Saline Control

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.

Group Type: ACTIVE_COMPARATOR

Saline control eye drops (15 ml)

Intervention Type: DRUG

Saline eye drops (15 ml)

Habitual contact lenses

Intervention Type: DEVICE

Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power

Interventions

FID 114657 eye drops (10 ml)

Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye

Intervention Type: DRUG

Saline control eye drops (15 ml)

Saline eye drops (15 ml)

Intervention Type: DRUG

Habitual contact lenses

Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power

Intervention Type: DEVICE

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Manager, Pharmaceuticals, Global Medical Affairs

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

LCO242-P001

Identifier Type: -

Identifier Source: org_study_id