Phase 3
Completed N=166
DE-111 Against Timolol Ophthalmic Solution 0.5%
Source: ClinicalTrials.gov NCT01342094 ↗Enrolled (actual)
166
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study — -3.2; -1.7 mmHg — p=< 0.001
Summary
DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, 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 |
-3.2; -1.7 | < 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 (NCT01342094). 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.