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

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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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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