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Clinical Trials/NCT01375582
NCT01375582
Completed
Early Phase 1

Objective Evaluation of Ocular Surface Lubricants

University of Rochester1 site in 1 country20 target enrollmentJune 2011

Overview

Phase
Early Phase 1
Intervention
B & L Soothe Lubricant Eye Drops
Conditions
Dry Eye
Sponsor
University of Rochester
Enrollment
20
Locations
1
Primary Endpoint
Tear Film Properties
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
June 2012
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

James V. Aquavella, MD

Principal Investigator

University of Rochester

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

Arms & Interventions

Drop Administration

Intervention: B & L Soothe Lubricant Eye Drops

Drop Administration

Intervention: Liposic EDO

Drop Administration

Intervention: OcuFresh Eye Wash

Outcomes

Primary Outcomes

Tear Film Properties

Time Frame: 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.

Study Sites (1)

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