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

Phase 1

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: 0.005% latanoprost; Drug: DE-104 medium concentration; Drug: DE-104 high concentration; Drug: Placebo

• Registration Number: NCT00868894
• Lead Sponsor: Santen Inc.

Brief Summary

To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-25
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Provided signed, written informed consent.
• 18 years of age and older.
• Diagnosed with primary open-angle glaucoma or ocular hypertension.
• 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	0.005% latanoprost	-
1	DE-104 medium concentration	-
2	DE-104 high concentration	-
3	Placebo	-

Primary Outcome Measures

Name	Time	Method
To compare the safety and efficacy of two concentrations of DE-104 ophthalmic solution with placebo and 0.005% latanoprost in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.	15 days

Secondary Outcome Measures

Name	Time	Method
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.	15 days