Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Not Applicable
Completed
- Conditions
- Dry Eye
- Interventions
- Drug: 0.1% sodium hyaluronate ophthalmic solution.
- Registration Number
- NCT01101984
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- Brief Summary
Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
-
Those who show:
- Keratoconjunctival disorder confirmed with vital dye staining
- Abnormal Schirmer score results
Exclusion Criteria
- Eye disease that needs therapy other than that for dry eye
- Those who need to wear contact lenses during the clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DE-089 diquafosol ophthalmic solution DE-089 ophthalmic solution DE-089 0.1% sodium hyaluronate ophthalmic solution. DE-089 ophthalmic solution HA 0.1% sodium hyaluronate ophthalmic solution. 0.1% sodium hyaluronate ophthalmic solution
- Primary Outcome Measures
Name Time Method Changes in the fluorescein and rose bengal staining score 2 weeks and 4 weeks from baseline. 1. Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority)
2. Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)
- Secondary Outcome Measures
Name Time Method Changes in tear film breakup time (second) 2 weeks and 4 weeks from baseline. Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation
Trial Locations
- Locations (2)
Singapore Eye Research Institute
🇸🇬Singapore, Singapore
Eye & Ear Hospital of Fudan University
🇨🇳Shanghai, China