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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00610480 |
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Date of registration:
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27/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tear Film Stability After Instillation of Over-the-Counter (OTC) Artificial Drops
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Scientific title:
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Effects of Systane® Versus Optive™ Lubricating Eye Drops in Maintaining Tear Film Stability at Determined Time Points |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00610480 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Vinod Mootha, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UTSW Medical Center at Dallas |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dry Eye Disease
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Intervention(s)
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Drug: 1st visit Optive, then 2nd visit Systane
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Drug: 1st visit Systane, then 2nd visit Optive
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Primary Outcome(s)
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Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears
[Time Frame: Baseline and 30 minutes after artificial tear instillation]
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Secondary ID(s)
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092007-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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