DE-111 Against Timolol Ophthalmic Solution 0.5%

Condition(s) targeted: Open Angle Glaucoma; Ocular Hypertension

Intervention: DE-111 ophthalmic solution (Drug); Timolol ophthalmic solution 0.5% (Drug); Placebo ophthalmic solution (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Santen Pharmaceutical Co., Ltd.

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.

Official title: A Double-masked Study of DE-111 Ophthalmic Solution Versus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Phase 3, Confirmatory Study -

Study design: Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Santen study sites, Osaka, Japan

Starting date: May 2011
Last updated: June 14, 2015