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

NCT00656240 | Completed Phase 2

• 1 other identifier: 01040703
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the intraocular pressure (IOP)-lowering effect and safety of DE-104 ophthalmic solution in patients with Primary Open-Angle Glaucoma or Ocular Hypertension

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Arms (2)

1

EXPERIMENTAL

Drug: DE-104 ophthalmic solution

2

EXPERIMENTAL

Drug: DE-104 vehicle

Interventions

DE-104 ophthalmic solution DRUG

1

DE-104 vehicle DRUG

2

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santen Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Osaka, Japan

Osaka, Japan

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Last Updated: March 16, 2009

Record last verified: 2009-03

Locations

JP (1)