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

Sponsor

Santen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00650338

Collaborator

(none)

165

Enrollment

Locations

Arms

Duration (Months)

11.8

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma Ocular Hypertension	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	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

165 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-masked, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 <described in intervention>	Drug: DE-104 ophthalmic solution, low concentration Topical ocular application
Experimental: 2 <described in intervention>	Drug: DE-104 ophthalmic solution, medium concentration Topical ocular application
Experimental: 3 <described in intervention>	Drug: DE-104 ophthalmic solution, high concentration Topical ocular application
Placebo Comparator: 4 <described in intervention>	Drug: Placebo placebo
Active Comparator: 5 <described intervention>	Drug: 0.005% latanoprost Topical ocular application

Outcome Measures

Primary Outcome Measures

To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP) [28 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sall Research Medical Center	Artesia	California	United States	90701
2	USC Department of Ophthalmology	Los Angeles	California	United States	90033
3	Wolstan Eye Associates	Torrance	California	United States	90505
4	East Florida Eye Institute	Stuart	Florida	United States	34994
5	Seidenberg Protzko Eye Associates	Bel Air	Maryland	United States	21014
6	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-5540
7	Rochester Ophthalmological Group, PC	Rochester	New York	United States	14618
8	Cornerstone Eye Care	High Point	North Carolina	United States	27262
9	Associated Glaucoma Consultants	Philadelphia	Pennsylvania	United States	19107
10	Keystone Research, Ltd.	Austin	Texas	United States	78731
11	David Shulman, MD P-A	San Antonio	Texas	United States	78209
12	Eye Clinics of South Texas	San Antonio	Texas	United States	78209
13	Medical Center Ophthalmology Associates	San Antonio	Texas	United States	78240
14	Virginia Eye Consultants	Norfolk	Virginia	United States	23507