NCT01030237CompletedNot Applicable
An Evaluation of the Safety and Efficacy of FID 114657
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 153
- Primary Endpoint
- Corneal Staining
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Documented diagnosis of dry eye
- •NaFl Corneal Staining sum score ≥ 3 in either eye
Exclusion Criteria
- •Must not have worn contact lenses for 1 week preceding enrollment
Outcomes
Primary Outcomes
Corneal Staining
Time Frame: measured at Days 0, 7, 14, 28 and 42
Tear Break-Up Time (TBUT)
Time Frame: measured at Days 0, 7, 14, 28 and 42
Conjunctival Staining
Time Frame: measured at Days 0, 7, 14, 28 and 42
Secondary Outcomes
No secondary outcomes reported
Investigators
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