Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-22

Study Completion Date

2014-06-23

Brief Summary

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To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.

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Detailed Description

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Conditions

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Hyperemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Brimonidine Tartrate

Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.

Group Type EXPERIMENTAL

Brimonidine Tartrate

Intervention Type DRUG

Ophthalmic solution to be applied as directed.

Sodium Fluorescein

Intervention Type DRUG

For use as needed during the study for evaluating corneal damage.

Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP

Intervention Type DRUG

For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Brimonidine Tartrate Vehicle

Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Ophthalmic solution to be applied as directed.

Sodium Fluorescein

Intervention Type DRUG

For use as needed during the study for evaluating corneal damage.

Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP

Intervention Type DRUG

For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Interventions

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Brimonidine Tartrate

Ophthalmic solution to be applied as directed.

Intervention Type DRUG

Vehicle

Ophthalmic solution to be applied as directed.

Intervention Type DRUG

Sodium Fluorescein

For use as needed during the study for evaluating corneal damage.

Intervention Type DRUG

Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP

For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity;
* Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.

Exclusion Criteria

* Have any ocular/systemic health problems
* Use of any disallowed medications during the period indicated prior to Baseline (Visit 1) and for the duration of the study.

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes