Objective Evaluation of Ocular Surface Lubricants in Two Environments

This study is currently recruiting participants.
Verified May 2012 by University of Rochester
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01375582
First received: June 14, 2011
Last updated: May 3, 2012
Last verified: May 2012

June 14, 2011
May 3, 2012
June 2011
June 2012   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01375582 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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 tear film and lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using wavefront sensing, ellipsometry, and thermal 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Dry Eye
  • Drug: B & L Soothe Lubricant Eye Drops
    Eye Drop
  • Drug: Liposic EDO
    Eye Drop
  • Drug: OcuFresh Eye Wash
    saline drop
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
June 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
Yes
Contact: Research Coordinator 585-273-4870 eyeclinicalstudies@urmc.rochester.edu
United States
 
NCT01375582
B&L 35809
No
University of Rochester
University of Rochester
Bausch & Lomb Incorporated
Not Provided
University of Rochester
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP