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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Hyperemia

Treatments: Drug: Vehicle; Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP; Drug: Sodium Fluorescein; Drug: Brimonidine Tartrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959230

861

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Any ocular/systemic health problems.
• Use of any disallowed medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Brimonidine Tartrate

Experimental group

Description:

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

Treatment:

Drug: Brimonidine Tartrate

Drug: Sodium Fluorescein

Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP

Brimonidine Tartrate Vehicle

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sodium Fluorescein

Drug: Vehicle

Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP