Formula Identification (FID) 114657 in Contact Lens Wearers

NCT02293538 | Completed Results

• 1 other identifier: LCO242-P001
• Study Type: interventional
• Target: 234
• Locations: 0 countries
• Sites: N/A

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

Keywords

Symptoms of Contact Lens Related Discomfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14

  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

  Baseline (Day 0), Day 14

• Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14

  Baseline (Day 0), Day 14

• Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14

  Day 14, after 2 hours of lens wear

Study Arms (2)

FID 114657

EXPERIMENTAL

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); Device: Habitual contact lenses

Saline Control

ACTIVE COMPARATOR

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); Device: Habitual contact lenses

Interventions

FID 114657 eye drops (10 ml) DRUG

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

FID 114657

Saline control eye drops (15 ml) DRUG

Saline eye drops (15 ml)

Saline Control

Habitual contact lenses DEVICE

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

FID 114657; Saline Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Global Brand Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, Pharmaceuticals, Global Medical Affairs

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 18, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 6, 2016
• Results First Posted: August 5, 2016

Record last verified: 2016-08