Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension

Eye Therapies, LLC

Status and phase: Completed; Phase 1

Conditions: Glaucoma and Ocular Hypertension

Treatments: Drug: Brimonidine Tartrate 0.025%; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01687426

12-150-0001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

Brimonidine Tartrate 0.025%

Active Comparator group

Treatment:

Drug: Brimonidine Tartrate 0.025%

Drug: Vehicle

Vehicle

Placebo Comparator group

Treatment:

Drug: Brimonidine Tartrate 0.025%

Drug: Vehicle