Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension
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
1 other identifier
interventional
49
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2009
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedNovember 3, 2011
November 1, 2011
1.2 years
March 23, 2009
November 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
15 days
Secondary Outcomes (1)
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.
15 days
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATOR4
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Provided signed, written informed consent.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Santen Inc.lead
Study Sites (6)
Unknown Facility
Artesia, California, 90701, United States
Unknown Facility
Pasadena, California, 91105, United States
Unknown Facility
San Francisco, California, 94102, United States
Unknown Facility
Honolulu, Hawaii, 96814, United States
Unknown Facility
Kailua, Hawaii, 96734, United States
Unknown Facility
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 25, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2010
Study Completion
June 1, 2010
Last Updated
November 3, 2011
Record last verified: 2011-11