drugset / Trial / NCT01342081
DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%
Parallel-groupTriple-blindTreatment
Summary
DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-09
- Completion
- —
Outcome
Met primary endpoint
registry analysis (superiority or other test); DE-111 vs Tafluprost; p < 0.001; Mean Difference (Final Values) -1.7 (95% CI -2.1 to -1.3); ANCOVA NCT01342081 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DE-111 | Unknown | — | Other |
| Comparator | Tafluprost | Other / unclassified | 0.0015 % | Other |
| Comparator | Timolol | Other / unclassified | 0.5 % | Other |