Objective Evaluation of Ocular Surface Lubricants in Two Environments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01375582
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : December 16, 2013
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
James V. Aquavella, MD, University of Rochester

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

Condition or disease Intervention/treatment Phase
Dry Eye Drug: B & L Soothe Lubricant Eye Drops Drug: Liposic EDO Drug: OcuFresh Eye Wash Early Phase 1

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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Objective Evaluation of Ocular Surface Lubricants
Study Start Date : June 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

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

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01375582

United States, New York
Flaum Eye Institute at the University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Bausch & Lomb Incorporated
Principal Investigator: James V Aquavella, MD University of Rochester

Responsible Party: James V. Aquavella, MD, Principal Investigator, University of Rochester Identifier: NCT01375582     History of Changes
Other Study ID Numbers: 35809
First Posted: June 17, 2011    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013

Keywords provided by James V. Aquavella, MD, University of Rochester:
Dry Eye
tear film
tear volume
environmental chamber
thermal imaging

Additional relevant MeSH terms:
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents