Overview

DE-111 Against Timolol Ophthalmic Solution 0.5%

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Details
Lead Sponsor:
Santen Pharmaceutical Co., Ltd.
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
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