Effects of Tear Film Stability After Instillation Of OTC Artificial Drops

This study has been completed.
Sponsor:
Collaborator:
Investigator initiated study
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00610480
First received: January 27, 2008
Last updated: July 13, 2009
Last verified: July 2009

January 27, 2008
July 13, 2009
November 2007
March 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00610480 on ClinicalTrials.gov Archive Site
Not Provided
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Effects of Tear Film Stability After Instillation Of OTC Artificial Drops
Effects of Systane® Versus Optive™ and Soothe™ Lubricating Eye Drops in Maintaining Tear Film Stability at Determined Time Points

The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ and Soothe™ 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Dry Eye Disease
  • Drug: Optive
    Instillation of Optive followed by Evaporametry assessment at 30 and 60 minutes
  • Drug: Systane
    Instillation of Systane followed by Evaporametry assessment at 30 and 60 minutes
  • Drug: Systane
  • Active Comparator: 1 Optive
    Intervention: Drug: Optive
  • Active Comparator: 2 Systane
    Interventions:
    • Drug: Systane
    • Drug: Systane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals aged 18 and up will be included, where any age over 89 will be recorded as 'greater than 89.'
  • Individuals with bilateral eye sight eye correctable to 20/80 or better.
  • Individuals in good health with or without Meibomian Gland Dystrophy (MGD) but with Aqueous Tear Deficiency (ATD) with minimal to no ocular surface inflammation on slit lamp examination.

Exclusion Criteria:

  • Individuals with only one sighted eye or vision not correctable to 20/80 or better in both eyes.
  • Individuals with history of punctal plugs or punctal occlusions.
  • Individuals with history of keratorefractive as well as ophthalmic disease such as corneal dystrophies, glaucoma, or systemic disease affecting the eye (such as Herpes Zoster).
  • Individuals with history of systemic or ocular auto-immune conditions.
  • Individuals with active systemic disease or those taking systemic medication that are known to influence AT production will not be considered for this trial.
  • Individuals using topical medication who are unable to discontinue them for at least 24 hours prior to baseline evaluation will be excluded as well.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00610480
092007-002
Yes
Mike Molai/Clinical Research Coordinator, UTSW Medical Center at Dallas/Department of Ophthalmology
University of Texas Southwestern Medical Center
Investigator initiated study
Principal Investigator: Vinod Motha, MD UTSW Medical Center at Dallas
University of Texas Southwestern Medical Center
July 2009

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