DE-111 Against Timolol Ophthalmic Solution 0.5%

Santen

Status and phase: Completed; Phase 3

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Timolol ophthalmic solution 0.5%; Drug: Placebo ophthalmic solution; Drug: DE-111 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01342094

01111005

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

166 participants in 2 patient groups

DE-111 ophthalmic solution

Experimental group

Description:

DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.

Treatment:

Drug: DE-111 ophthalmic solution

Drug: Placebo ophthalmic solution

Timolol ophthalmic solution 0.5%

Active Comparator group

Description:

Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.

Treatment:

Drug: Timolol ophthalmic solution 0.5%

Drug: Placebo ophthalmic solution