Phase 3
Completed N=287
Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Source: ClinicalTrials.gov NCT01240382 ↗Enrolled (actual)
287
Serious AEs
0.4%
Results posted
Aug 2014
Primary outcomePrimary: Mean Change in Fluorescein Staining Score From Baseline — -2.12; -2.08 points
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.
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 |
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. Informational only — not medical advice.