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

NCT ID: NCT01687426

Last Updated: 2012-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma and Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Brimonidine Tartrate 0.025%

Group Type ACTIVE_COMPARATOR

Brimonidine Tartrate 0.025%

Intervention Type DRUG

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

Vehicle

Intervention Type DRUG

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

Vehicle

Group Type PLACEBO_COMPARATOR

Brimonidine Tartrate 0.025%

Intervention Type DRUG

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

Vehicle

Intervention Type DRUG

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

Interventions

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Brimonidine Tartrate 0.025%

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

Intervention Type DRUG

Vehicle

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye Therapies, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Site

Winchester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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12-150-0001

Identifier Type: -

Identifier Source: org_study_id