Effects of Tear Film Stability After Instillation Of OTC Artificial Drops
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|ClinicalTrials.gov Identifier: NCT00610480|
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : July 14, 2009
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Disease||Drug: Optive Drug: Systane||Not Applicable|
Twenty (20) patients will be enrolled in this three -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, and evaporometry 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 three treatment groups. After 1 hour, in order to eliminate any residual sodium fluorescein, patients will be administered one drop of Systane® (40 µl), Optive™ (40 µl), or and Soothe™ (40 µl) in each eye per randomization assignment. At 30 and 60 minutes following instillation of drop, evaporometry measurement 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 and 3rd 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 prior to one hour of their office visits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Systane® Versus Optive™ and Soothe™ Lubricating Eye Drops in Maintaining Tear Film Stability at Determined Time Points|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
|Active Comparator: 1 Optive||
Instillation of Optive followed by Evaporametry assessment at 30 and 60 minutes
|Active Comparator: 2 Systane||
Instillation of Systane followed by Evaporametry assessment at 30 and 60 minutes
- To evaluate tear film stability after the use of OTC ATwhen using an Evaporometer in patients with a diagnosis of Keratoconjunctivitis Sicca (KCS). [ Time Frame: 4 months ]
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): NCT00610480
|United States, Texas|
|UTSW Medical Center at Dallas - Aston Ambulatory Care Center|
|Dallas, Texas, United States, 75390-9057|
|Principal Investigator:||Vinod Motha, MD||UTSW Medical Center at Dallas|