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Dose-Response Study of DE-089 in Dry Eye
NCT01189032Phase 2
Key facts
- Status
- Completed
- Primary completion
- Jul 2006
- Countries
- 1
- Sponsor
- Santen Pharmaceutical
- Modality
- Small Molecules
- Drugs
- diquafosol
- Conditions
- dry eye disease (DED)
01
Overview
Phase 2, randomised, double-blind trial of diquafosol in dry eye disease (DED) (3 arms), sponsored by Santen Pharmaceutical. Primary endpoint: Mean Change in Fluorescein Staining Score From Baseline at 4 weeks. Status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
High concentration
DE-089 ophthalmic solution (High concentration)
Low concentration
DE-089 ophthalmic solution (Low concentration)
Placebo
Placebo ophthalmic solution
03
Who it enrols
Patients with keratoconjunctival disorder confirmed with vital dye staining and abnormal Schirmer score results.
04
Endpoints
Primary
Mean Change in Fluorescein Staining Score From Baseline
05
Results
Primary endpoints met
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