Phase 3
Completed N=489
DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%
Source: ClinicalTrials.gov NCT01342081 ↗Enrolled (actual)
489
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study — -2.6; -0.9; -2.2 mmHg — p=< 0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study |
-2.6; -0.9; -2.2 | < 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with primary open angle glaucoma or ocular hypertension
- Provided signed, written informed consent
- 20 years of age and older
- If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
Exclusion Criteria
- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
- Presence of any abnormality or significant illness that could be expected to interfere with the study.
Data sourced from ClinicalTrials.gov (NCT01342081). 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.