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

Phase 2

Completed

• Conditions: Ocular Redness
• Interventions: Drug: Brimonidine tartrate 0.025%; Drug: Placebo

• Registration Number: NCT01675609
• Lead Sponsor: Eye Therapies, LLC

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-30
• Primary Completion: 2012-10
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-28
• Disposition First Submitted QC: 2014-07-28
• Last Update Submitted: 2014-07-28
• Disposition First Posted: 2014-07-31
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brimonidine Tartrate 0.025%	Brimonidine tartrate 0.025%	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Ocular Redness	up to 5 minutes post study medication instillation	evaluated prior to study medication instillation and at 5 minutes post instillation

Trial Locations

Locations (1)

Ora, Inc.; 🇺🇸 Andover, Massachusetts, United States