Objective Evaluation of Ocular Surface Lubricants in Two Environments

Objective Evaluation of Ocular Surface Lubricants

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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: B & L Soothe Lubricant Eye Drops; Drug: Liposic EDO; Drug: OcuFresh Eye Wash

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Flaum Eye Institute at the University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drop Administration	Drug: B & L Soothe Lubricant Eye Drops; Eye Drop; Drug: Liposic EDO; Eye Drop; Drug: OcuFresh Eye Wash; Saline drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Film Properties	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.	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.

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: James V Aquavella, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 14, 2011
• First Submitted That Met QC Criteria: June 15, 2011
• First Posted (Estimate): June 17, 2011

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 19, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Dry Eye; tear film; thermal imaging; lipid; tear volume; environmental chamber
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: 35809