Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension
This study has been completed.
Sponsor:
Santen Inc.
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00650338
First received: March 27, 2008
Last updated: November 1, 2011
Last verified: November 2011
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Purpose
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 | Intervention | 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 Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
Drug Information available for:
Latanoprost
U.S. FDA Resources
Further study details as provided by Santen Inc.:
Primary Outcome Measures:
- To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 165 |
| Study Start Date: | March 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650338
Locations
| United States, California | |
| Sall Research Medical Center | |
| Artesia, California, United States, 90701 | |
| USC Department of Ophthalmology | |
| Los Angeles, California, United States, 90033 | |
| Wolstan Eye Associates | |
| Torrance, California, United States, 90505 | |
| United States, Florida | |
| East Florida Eye Institute | |
| Stuart, Florida, United States, 34994 | |
| United States, Maryland | |
| Seidenberg Protzko Eye Associates | |
| Bel Air, Maryland, United States, 21014 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-5540 | |
| United States, New York | |
| Rochester Ophthalmological Group, PC | |
| Rochester, New York, United States, 14618 | |
| United States, North Carolina | |
| Cornerstone Eye Care | |
| High Point, North Carolina, United States, 27262 | |
| United States, Pennsylvania | |
| Associated Glaucoma Consultants | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Keystone Research, Ltd. | |
| Austin, Texas, United States, 78731 | |
| Medical Center Ophthalmology Associates | |
| San Antonio, Texas, United States, 78240 | |
| Eye Clinics of South Texas | |
| San Antonio, Texas, United States, 78209 | |
| David Shulman, MD P-A | |
| San Antonio, Texas, United States, 78209 | |
| United States, Virginia | |
| Virginia Eye Consultants | |
| Norfolk, Virginia, United States, 23507 | |
Sponsors and Collaborators
Santen Inc.
More Information
No publications provided
| Responsible Party: | Santen Inc. |
| ClinicalTrials.gov Identifier: | NCT00650338 History of Changes |
| Other Study ID Numbers: | 27-002 |
| Study First Received: | March 27, 2008 |
| Last Updated: | November 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases |
Cardiovascular Diseases Latanoprost Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013