Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-07

Study Completion Date

2013-12-20

Brief Summary

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To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.

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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

TREATMENT

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

* At least 18 years of age.
* Have a history of redness relief drops use or expressed a desire to use drops for redness relief, within the last 6 months.
* Have ocular health within normal limits including a calculated best-corrected visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart.