Effects of Systane Versus Saline in Maintaining Tear Film Stability at Determined Time Points
Drug: Systane Ocular Drops (OTC)
Drug: Placebo - Saline Drops
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Systane Versus Saline in Maintaining Tear Film Stability at Determined Time Points|
- Evaporametry changes pre and post instillation of test articles in patients with KCS [ Time Frame: In Clinic Visit ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
The goal of this research is to evaluate and compare the effectiveness of Systane® versus saline on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.
Twelve (12) patients will be enrolled in this two-period crossover, randomized study design. During the course of the study, each patient will be treated with each test articles in the clinic at separate visits. Following the informed consent procedure, a general ocular evaluation, including corneal and conjunctival staining, Schirmer testing, evaporometry, and interferometry assessments will be completed to determine baseline tear evaporation rate. This will occur before any test article is administered to the patient.
Qualified patients will be randomized into two treatment groups. After 1 hour, in order to eliminate any residual sodium fluorescein, patients will be administered one drop of Systane® (40 µl) or saline (40 µl) in each eye per randomization assignment. At 30 and 60 minutes following instillation of drop, evaporometry and interferometry measurements will be repeated again. These tests (pre and post instillation of drops) will be performed in order to establish a comparison for later analysis. The estimated time in completing these visits will be 180 minutes per visit. Patients will be asked to return to the clinic after 2 - 14 days for evaluation of the 2nd assigned treatment.
During the interim study periods, patients will be asked to continue their pre-study routine; using their pre-study ocular lubricant or other tear products at the same frequency. Any changes in the frequency of product use during the interim period or any changes in other concomitant medications will be carefully recorded. This is especially important since many prescription products (e.g., Claritan) have significant effects on lacrimal gland physiology.
An effort will be made to schedule all study visits at approximately the same time of day in order to reduce diurnal variability. For the similar reasons, all patients will be asked not to use any lubricants or ocular medications within one hour of their office visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345241
|United States, Texas|
|University of Texas Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390-8866|
|Principal Investigator:||Harrison D. Cavanagh, M.D.||University of Texas, Southwestern Medical Center at Dallas|