Ocular Hypertension Clinical Trial
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
| Verified date | November 2011 |
| Source | Santen Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 165 |
| Est. completion date | October 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Sall Research Medical Center | Artesia | California |
| United States | Keystone Research, Ltd. | Austin | Texas |
| United States | Seidenberg Protzko Eye Associates | Bel Air | Maryland |
| United States | Cornerstone Eye Care | High Point | North Carolina |
| United States | USC Department of Ophthalmology | Los Angeles | California |
| United States | Virginia Eye Consultants | Norfolk | Virginia |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Associated Glaucoma Consultants | Philadelphia | Pennsylvania |
| United States | Rochester Ophthalmological Group, PC | Rochester | New York |
| United States | David Shulman, MD P-A | San Antonio | Texas |
| United States | Eye Clinics of South Texas | San Antonio | Texas |
| United States | Medical Center Ophthalmology Associates | San Antonio | Texas |
| United States | East Florida Eye Institute | Stuart | Florida |
| United States | Wolstan Eye Associates | Torrance | California |
| Lead Sponsor | Collaborator |
|---|---|
| Santen Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP) | 28 days | ||
| Secondary | To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost. | 35 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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