Completed

Objective Evaluation of Ocular Surface Lubricants

What is being tested

B & L Soothe Lubricant Eye Drops

+ Liposic EDO

+ OcuFresh Eye Wash

Drug

Who is being recruted

Eye Diseases

+ Lacrimal Apparatus Diseases

+ Dry Eye Syndromes

From 30 to 75 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Early Phase 1

Interventional

Study Start: June 2011

See protocol details

Summary

Principal SponsorUniversity of Rochester

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

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.

Official TitleObjective Evaluation of Ocular Surface Lubricants

NCT01375582

Principal SponsorUniversity of Rochester

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

5 inclusion criteria required to participate

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.

Show More Criteria

4 exclusion criteria prevent from participating

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Flaum Eye Institute at the University of Rochester

Rochester, United StatesOpen Flaum Eye Institute at the University of Rochester in Google Maps

CompletedOne Study Center