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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01687426

Enrollment

Registered

2012-09-19

Start date

2012-09-30

Completion date

2012-12-31

Last updated

2012-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma and Ocular Hypertension

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.

Interventions

DRUGBrimonidine Tartrate 0.025%

1 drop in each eye daily four times a day for 14 days

DRUGVehicle

1 drop in each eye daily four times a day for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
IOP	14 days

Other

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety	For up to 8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026