DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

Santen

Status and phase: Completed; Phase 3

Conditions: Open Angle Glaucoma or Ocular Hypertension

Treatments: Drug: DE-111 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01343082

01111006

Details and patient eligibility

About

Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.

Enrollment: 148 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with 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

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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148 participants in 1 patient group

1

Experimental group

Description:

DE-111 ophthalmic solution

Treatment:

Drug: DE-111 ophthalmic solution