Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension

Phase 2

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: DE-104 ophthalmic solution, low concentration; Drug: DE-104 ophthalmic solution, high concentration; Drug: DE-104 vehicle; Drug: DE-104 ophthalmic solution, medium concentration

• Registration Number: NCT00657579
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

Brief Summary

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-12
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosed with primary open-angle glaucoma or ocular hypertension.
• Provided signed, written informed consent.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	DE-104 ophthalmic solution, low concentration	-
3	DE-104 ophthalmic solution, high concentration	-
4	DE-104 vehicle	-
2	DE-104 ophthalmic solution, medium concentration	-

Trial Locations

Locations (1)

Osaka, Japan; 🇯🇵 Osaka, Japan