Phase 3
N=287
Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT01240382 ↗Enrolled (actual)
287
Serious AEs
0.4%
Results posted
Aug 2014
Primary outcome: Primary: Mean Change in Fluorescein Staining Score From Baseline — -2.12; -2.08 points
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 3% DE-089 ophthalmic solution (Drug); 0.1% sodium hyaluronate ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Fluorescein Staining Score From Baseline |
-2.12; -2.08 | — |
| PRIMARY Mean Change in Rose Bengal Staining Score From Baseline |
-3.06; -2.38 | 0.010 sig |
Summary
To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.
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 (NCT01240382). 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.