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, medium concentration; Drug: DE-104 ophthalmic solution, high concentration; Drug: Placebo; Drug: 0.005% latanoprost

• Registration Number: NCT00650338
• Lead Sponsor: Santen Inc.

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 Start: 2008-03
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Provided signed, written informed consent.
• Diagnosed with primary open-angle glaucoma or ocular hypertension.
• 18 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	DE-104 ophthalmic solution, low concentration	\<described in intervention\>
2	DE-104 ophthalmic solution, medium concentration	\<described in intervention\>
3	DE-104 ophthalmic solution, high concentration	\<described in intervention\>
4	Placebo	\<described in intervention\>
5	0.005% latanoprost	\<described intervention\>

Primary Outcome Measures

Name	Time	Method
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)	28 days

Secondary Outcome Measures

Name	Time	Method
To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.	35 days

Trial Locations

Locations (14)

Associated Glaucoma Consultants; 🇺🇸 Philadelphia, Pennsylvania, United States

Sall Research Medical Center; 🇺🇸 Artesia, California, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Seidenberg Protzko Eye Associates; 🇺🇸 Bel Air, Maryland, United States

Cornerstone Eye Care; 🇺🇸 High Point, North Carolina, United States

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States

Rochester Ophthalmological Group, PC; 🇺🇸 Rochester, New York, United States

USC Department of Ophthalmology; 🇺🇸 Los Angeles, California, United States

Wolstan Eye Associates; 🇺🇸 Torrance, California, United States

East Florida Eye Institute; 🇺🇸 Stuart, Florida, United States

Keystone Research, Ltd.; 🇺🇸 Austin, Texas, United States

Eye Clinics of South Texas; 🇺🇸 San Antonio, Texas, United States

Virginia Eye Consultants; 🇺🇸 Norfolk, Virginia, United States

David Shulman, MD P-A; 🇺🇸 San Antonio, Texas, United States