Clinical Efficacy of Two Topical Dry Eye Drops for Central Corneal Stain Clearing Over 90 Days
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dry Eye
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Masking Description: study medication will be provided in an unmarked box with tape externally covering any identifying languagePrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
The study will be a randomized, double-blind prospective study in 3 sites in the US to compare efficacy of improvement in central corneal staining with fluorescein dye evaluations at slit lamp exam, secondarily improvement in OSDI questionnaire with additional questions regarding dysgeusia, blurrine...
The study will be a randomized, double-blind prospective study in 3 sites in the US to compare efficacy of improvement in central corneal staining with fluorescein dye evaluations at slit lamp exam, secondarily improvement in OSDI questionnaire with additional questions regarding dysgeusia, blurriness, and sensation of burning, improvements in corneal topography and improvements in Schirmer's testing. 100 study subjects 18-85 male or female will be enrolled in the Nashville, Beverly Hills and St. Louis areas who are generally healthy with central corneal staining and scheduled for uncomplicated phacoemulsification or uncomplicated LASIK.
Tracking Information
- NCT #
- NCT04172961
- Collaborators
- Sun Pharmaceutical Industries Limited
- Investigators
- Not Provided