Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345241
Status:
COMPLETED
Last Update Posted:
2008-06-23
First Post:
2006-06-23
Brief Title:
Effects of Systane Versus Saline in Maintaining Tear Film Stability at Determined Time Points
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Effects of Systane Versus Saline in Maintaining Tear Film Stability at Determined Time Points
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate tear film stability of a market lubricant therapeutic eye drop versus saline when using Evaporometry and Interferometry in patients with a diagnosis of Keratoconjunctivitis Sicca KCS The purpose of this research is to evaluate evaporative parameters and tear film quality when using Systane lubricating eye drops versus saline in the eyes of dry eye patients at pre-instillation and at 30 and 60 minutes post instillation of drops
Detailed Description:
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None