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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Hyperemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959243

862

Details and patient eligibility

About

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.

Enrollment: 507 patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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507 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: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP

Drug: Vehicle