Objective Evaluation of Ocular Surface Lubricants in Two Environments

Early Phase 1

Completed

• Conditions: Dry Eye
• Interventions: Drug: B & L Soothe Lubricant Eye Drops; Drug: Liposic EDO; Drug: OcuFresh Eye Wash

• Registration Number: NCT01375582
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-17
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-19
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Drop Administration	B & L Soothe Lubricant Eye Drops	-
Drop Administration	Liposic EDO	-
Drop Administration	OcuFresh Eye Wash	-

Primary Outcome Measures

Name	Time	Method
Tear Film Properties	Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit.	The wavefront sensor instrument measures the eye's ability to create a sharp image.; Ellipsometer (E) data identifies changes in lipid thickness and refractive index over the cornea.; A thermal (T) imaging system provides thermal maps of the subject's eyes and face adjacent to the eyes.; A questionnaire (Q) will ask subjects about their test eye's comfort. Subjects will be asked the questions prior to instillation of the eye drop and after each set of measurements.

Trial Locations

Locations (1)

Flaum Eye Institute at the University of Rochester; 🇺🇸 Rochester, New York, United States