Objective Evaluation of Ocular Surface Lubricants in Two Environments

NCT ID: NCT01375582

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-06-30

Brief Summary

This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.

Detailed Description

This study will objectively evaluate ocular surface lubricants in subjects with dry eye syndrome. Lubricants contain compounds that are purported to improve dry eye symptoms, although objective data is not available. The investigators seek to objectively evaluate the effectiveness of two lubricants and compare the results to a saline eye drop (control).

The investigators will assess the lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using the ellipsometry, imaging in a "normal" environment. Subsequently the investigators will change the environment to one that causes the subjects' ocular surface to experience "evaporative stress" (warmer, less humid and greater air flow) and perform the before and after drop administration measurements with the same three products in the same eye as the first environment.

Conditions

Dry Eye

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drop Administration

Group Type: EXPERIMENTAL

B & L Soothe Lubricant Eye Drops

Intervention Type: DRUG

Eye Drop

Liposic EDO

Intervention Type: DRUG

Eye Drop

OcuFresh Eye Wash

Intervention Type: DRUG

Saline drop

Interventions

B & L Soothe Lubricant Eye Drops

Eye Drop

Intervention Type: DRUG

Liposic EDO

Eye Drop

Intervention Type: DRUG

OcuFresh Eye Wash

Saline drop

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 30-75 years
• Good general health
• Willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits
• Currently using an OTC artificial tear for ocular comfort, at least occasionally.
• At least one positive dry eye symptom.

Exclusion Criteria

• Current eye disease, infection or inflammation that requires the use of any prescription ocular medication.
• Recent past eye surgery.
• Female subjects may not be pregnant or lactating.
• Infectious diseases

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

James V. Aquavella, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James V Aquavella, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Flaum Eye Institute at the University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

35809

Identifier Type: -

Identifier Source: org_study_id