Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
NCT ID: NCT01010282
Last Updated: 2015-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
288 participants
INTERVENTIONAL
2009-11-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Glycerin and Polysorbate 80 based artificial tear
Glycerin and Polysorbate 80 based artificial tear
Glycerin and Polysorbate 80 based artificial tear
1-2 drops in each eye, as needed, but at least twice daily
Artificial Tears Formulation 1
Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear
Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear
1-2 drops in each eye, as needed, but at least twice daily
Artificial Tears Formulation 2
Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
1-2 drops in each eye, as needed, but at least twice daily
Interventions
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Glycerin and Polysorbate 80 based artificial tear
1-2 drops in each eye, as needed, but at least twice daily
Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear
1-2 drops in each eye, as needed, but at least twice daily
Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
1-2 drops in each eye, as needed, but at least twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability/agreement to wear habitual correction (glasses) during study period
Exclusion Criteria
* Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
* Chronic use of systemic medications which may affect a dry eye condition
* Active ocular allergy or infection
* Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1
* Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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San Diego, California, United States
Countries
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References
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Simmons PA, Carlisle-Wilcox C, Chen R, Liu H, Vehige JG. Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. Clin Ther. 2015 Apr 1;37(4):858-68. doi: 10.1016/j.clinthera.2015.01.001. Epub 2015 Feb 4.
Other Identifiers
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AG9965-002
Identifier Type: -
Identifier Source: org_study_id
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