NCT03216096
Completed
Phase 1
A Prospective, Open Label, One-arm, 4-weeks Study Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease -Phase 1 Study in Dry Eye Patients
ConditionsDry Eye Disease
Overview
- Phase
- Phase 1
- Intervention
- Placebo ophthalmic solution and 3% DE-089 ophthalmic solution
- Conditions
- Dry Eye Disease
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Corneal fluorescein staining score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
3% DE-089 ophthalmic solution
Intervention: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution
Outcomes
Primary Outcomes
Corneal fluorescein staining score
Time Frame: Week 4
Change in corneal fluorescein staining score at week 4/ at the time of discontinuation
Study Sites (2)
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