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Effects of Tear Film Stability After Instillation Of OTC Artificial Drops

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. Identifier: NCT00610480
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : July 14, 2009
Investigator initiated study
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Optive Drug: Systane Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Systane

Arm Intervention/treatment
Active Comparator: 1 Optive Drug: Optive
Instillation of Optive followed by Evaporametry assessment at 30 and 60 minutes

Active Comparator: 2 Systane Drug: Systane
Instillation of Systane followed by Evaporametry assessment at 30 and 60 minutes

Drug: Systane

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00610480

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United States, Texas
UTSW Medical Center at Dallas - Aston Ambulatory Care Center
Dallas, Texas, United States, 75390-9057
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigator initiated study
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Principal Investigator: Vinod Motha, MD UTSW Medical Center at Dallas
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Responsible Party: Mike Molai/Clinical Research Coordinator, UTSW Medical Center at Dallas/Department of Ophthalmology Identifier: NCT00610480    
Other Study ID Numbers: 092007-002
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009
Keywords provided by University of Texas Southwestern Medical Center:
Dry Eyes
Tear Film Stability
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases