CompletedInterventionalNot ApplicableUpdated Dec 14, 2011
Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects | NCT01010282 | Trialant
CompletedInterventionalNot ApplicableUpdated Aug 17, 2015
Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
ClinicalTrials.gov ID
NCT01010282
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
288Actual
Last Update Posted
Aug 17, 2015Estimated
Start Date
Nov 2009
Primary Completion Date
Apr 2010Actual
Completion Date
Apr 2010Actual
Brief Summary
This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.
Dry Eye Syndrome
Glycerin and Polysorbate 80 based artificial tear
Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear
Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average
Ability/agreement to wear habitual correction (glasses) during study period
Exclusion Criteria:
Known allergy or sensitivity to the study product(s) or its components
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.