Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects

Eye Therapies, LLC57 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily in a population of adult and geriatric subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ocular Redness

Interventions

PlaceboDRUG

1 drop in each eye daily for up to 35 days

Brimonidine tartrate 0.025%DRUG

1 drop in each eye for up to 35 days

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Be at least 40 years of age * Must have normal ocular health * Must have history of redness relief drop use or desire to use Exclusion Criteria: * Must not have any ocular/systemic health problems * Must agree to avoid disallowed medications

Locations (1)

Ora, Inc.

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Ocular redness

redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary

Time frame: at specified timepoints for up to 180 minutes

Secondary Outcomes

Ocular Redness

evaluated prior to study medication instillation and at 5 minutes post instillation

Time frame: up to 5 minutes post study medication instillation

Data from ClinicalTrials.gov

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