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

A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01675609

Enrollment

Registered

2012-08-30

Start date

2012-08-31

Completion date

Unknown

Last updated

2014-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Redness

Brief summary

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

Interventions

DRUGPlacebo

1 drop in each eye daily for up to 35 days

DRUGBrimonidine tartrate 0.025%

1 drop in each eye for up to 35 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Ocular redness	at specified timepoints for up to 180 minutes	redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary

Secondary

Measure	Time frame	Description
Ocular Redness	up to 5 minutes post study medication instillation	evaluated prior to study medication instillation and at 5 minutes post instillation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026