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.|
|ClinicalTrials.gov Identifier: NCT01375582|
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : December 16, 2013
|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|
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)|
|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|
|Experimental: Drop Administration||
Drug: B & L Soothe Lubricant Eye Drops
Eye DropDrug: Liposic EDO
Eye DropDrug: OcuFresh Eye Wash
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01375582
|United States, New York|
|Flaum Eye Institute at the University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||James V Aquavella, MD||University of Rochester|