Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma
A Randomized, Parallel-Group, Multi-Center, Investigator-Masked, Active-and Placebo-Controlled, Phase 1-2 Evaluation of the Safety and Efficacy of OT-730 Ophthalmic Solution in Reducing the Intraocular Pressure in Subjects With Ocular Hypertension or Open-Angle Glaucoma
1 other identifier
interventional
48
1 country
5
Brief Summary
The purpose of this study is to evaluate the safety and potential efficacy of a new drug, OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of patients with open angle glaucoma or ocular hypertension. It will be compared with commercial timolol and placebo eye drops.
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 Sep 2008
Shorter than P25 for phase_1
5 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
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 8, 2008
CompletedFirst Posted
Study publicly available on registry
September 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 7, 2009
January 1, 2009
3 months
September 8, 2008
January 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assess the safety profile of OT-730
8 days
Change from baseline in intraocular pressure
Day 6
Study Arms (3)
1
EXPERIMENTALOT-730 ophthalmic solution
2
ACTIVE COMPARATORtimolol maleate ophthalmic solution
3
PLACEBO COMPARATORplacebo eye drops
Interventions
Eligibility Criteria
You may qualify if:
- healthy subjects, 18 to 80 years of age, any gender
- diagnosis of primary open angle, pseudoexfoliative or pigmentary glaucoma or ocular hypertension
You may not qualify if:
- have VA worse than 20/200,
- cataract that compromises visualization of fundus,
- history of lack of response to ocular beta blocker therapy,
- uncontrolled intraocular pressure,
- angle closure glaucoma or occludable angles,
- retinal detachment, macular hole, progressive vision loss, any progressive retinal disease or neurologic disease other than glaucoma that is likely to worsen visual field or acuity during the course of the study,
- a history of, or any current condition contraindicated with use of a beta blocker (e.g., chronic obstructive pulmonary disease, bronchial asthma, congestive heart failure, myasthenia gravis, hypoglycemia, bradycardia, etc),
- chronic use of steroids,
- any disease that, in the opinion of the investigator, may put the patient at significant risk,
- taking systemic beta blockers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Artesia, California, United States
Unknown Facility
Roswell, Georgia, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
High Point, North Carolina, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2008
First Posted
September 16, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 7, 2009
Record last verified: 2009-01