Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension
A Single-Center, Randomized, Double-Masked, Cross-Over Pilot Study Evaluating Safety and IOP Lowering Response of Brimonidine Tartrate Ophthalmic Solution Versus Vehicle in Subjects With Open Angle Glaucoma or Ocular Hypertension
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to determine the intraocular Pressure (IOP) lowering response and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects with 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 below P25 for phase_1
Started Sep 2012
Shorter than P25 for phase_1
1 active site
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, 2012
CompletedFirst Submitted
Initial submission to the registry
September 5, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 25, 2012
December 1, 2012
3 months
September 5, 2012
December 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
IOP
14 days
Other Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety
For up to 8 weeks
Study Arms (2)
Brimonidine Tartrate 0.025%
ACTIVE COMPARATORVehicle
PLACEBO COMPARATORInterventions
1 drop in each eye daily four times a day for 14 days
Eligibility Criteria
You may qualify if:
- Be at least 18 years of age at Visit 1 (Screening), of either sex and any race
- Be willing and able to provide written informed consent prior to any study procedures being performed.
- Be willing and able to follow all instructions and attend all study visits.
- Be willing to discontinue use of disallowed medication
- Have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic angle closure glaucoma with a patent iridotomy.
You may not qualify if:
- Have known sensitivity or poor tolerance to brimonidine or any other component of the study medications.
- Have any form of glaucoma other than open-angle glaucoma, ocular hypertension or chronic angle closure glaucoma with patent iridotomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Site
Winchester, Massachusetts, 01890, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2012
First Posted
September 19, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 25, 2012
Record last verified: 2012-12