NCT01687426CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eye Therapies, LLC
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- IOP
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Brimonidine Tartrate 0.025%
Active Comparator
Intervention: Brimonidine Tartrate 0.025% (Drug)
Brimonidine Tartrate 0.025%
Active Comparator
Intervention: Vehicle (Drug)
Vehicle
Placebo Comparator
Intervention: Brimonidine Tartrate 0.025% (Drug)
Vehicle
Placebo Comparator
Intervention: Vehicle (Drug)
Outcomes
Primary Outcomes
IOP
Time Frame: 14 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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