Phase 2
N=286
Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT01189032 ↗Enrolled (actual)
286
Serious AEs
0.4%
Results posted
Aug 2014
Primary outcome: Primary: Mean Change in Fluorescein Staining Score From Baseline — -0.95; -1.34; -1.55 points — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DE-089 ophthalmic solution (Drug); Placebo ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Fluorescein Staining Score From Baseline |
-0.95; -1.34; -1.55 | 0.004 sig |
Summary
Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01189032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.