Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease
Phase 1
Completed
- Conditions
- Dry Eye Disease
- Interventions
- Drug: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution
- Registration Number
- NCT03216096
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- Brief Summary
The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in patients with dry eye disease in Taiwan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- At least 6-month dry eye history
Exclusion Criteria
- Diagnosed with Stevens-Johnson Syndrome or ocular pemphigoid
- Diagnosed with keratoconjunctival chemical burns or thermal burn
- Eye disease other than dry eye disease which needs treatment
- Allergic conjunctivitis that may possibly be aggravated during the clinical study and inappropriate for efficacy evaluation
- Those who need to wear contact lenses during the clinical study
- Those who are considered inappropriate for this study by the investigator or subinvestigators
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 3% DE-089 ophthalmic solution Placebo ophthalmic solution and 3% DE-089 ophthalmic solution -
- Primary Outcome Measures
Name Time Method Corneal fluorescein staining score Week 4 Change in corneal fluorescein staining score at week 4/ at the time of discontinuation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Keelung Chang Gung Memorial Hospital
🇨🇳Keelung, Taiwan