DE-111 Against Timolol Ophthalmic Solution 0.5%

Phase 3CompletedNCT01342094

Santen Pharmaceutical Co., Ltd.166 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

166

Conditions

Open Angle Glaucoma Ocular Hypertension

Interventions

DE-111 ophthalmic solutionDRUG

Timolol ophthalmic solution 0.5%DRUG

Placebo ophthalmic solutionDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Santen study sites

Osaka, Osaka, Japan

Outcomes

Primary Outcomes

Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study

Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.

Time frame: Week 0(Baseline) and Week 4(End of Study)

Data from ClinicalTrials.gov

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