Skip to main content
OpenTrials
Completed

NCT Number: NCT01375582

Objective Evaluation of Ocular Surface Lubricants in Two Environments

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Flaum Eye Institute at the University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B & L Soothe Lubricant Eye Drops

Drug

Eye Drop

Liposic EDO

Drug

Eye Drop

OcuFresh Eye Wash

Drug

Saline drop

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Bausch & Lomb Incorporated

Registry information

Official study title

Objective Evaluation of Ocular Surface Lubricants

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2011
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.