Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension - Full Text View

Sponsored by:	Santen Inc.
Information provided by:	Santen Inc.
ClinicalTrials.gov Identifier:	NCT00868894

Purpose

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.

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: DE-104 medium concentration Drug: DE-104 high concentration Drug: Placebo Drug: 0.005% latanoprost	Phase I Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Masked, Placebo- and Active-Controlled, Multi-Center, Dose Escalation Trial of DE-104 Ophthalmic Solution in Japanese and Non-Japanese Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Further study details as provided by Santen Inc.:

Primary Outcome Measures:

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. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	March 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: DE-104 medium concentration Topical ocular application
2: Experimental	Drug: DE-104 high concentration Topical ocular application
3: Placebo Comparator	Drug: Placebo Topical ocular application
4: Active Comparator	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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868894

Contacts

Contact: Mark Holdbrook

707-256-1424

mholdbrook@santeninc.com

Locations

United States, California
	Not yet recruiting
Los Angeles, California, United States, 90013
	Recruiting
San Francisco, California, United States, 94102
United States, Hawaii
	Recruiting
Honolulu, Hawaii, United States, 96814
United States, New York
	Recruiting
New York, New York, United States, 10021
	Recruiting
Fleetwood, New York, United States, 10552

Sponsors and Collaborators

Santen Inc.

More Information

No publications provided

Responsible Party:	Santen Incorporated ( Mark Holdbrook/Vice President, Clinical Affairs )
Study ID Numbers:	27-003
Study First Received:	March 23, 2009
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00868894 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Therapeutic Uses
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Latanoprost
Pharmacologic Actions
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009