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

Ocular Redness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675609
• Other study ID #: 11-100-0015
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2012
• Last updated: July 28, 2014
• Start date: August 2012

Study information

• Verified date: July 2014
• Source: Eye Therapies, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ocular Redness

Intervention

Drug:
• Placebo
1 drop in each eye daily for up to 35 days
• Brimonidine tartrate 0.025%
1 drop in each eye for up to 35 days

Locations

Country	Name	City	State
United States	Ora, Inc.	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eye Therapies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular redness	redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary	at specified timepoints for up to 180 minutes	No
Secondary	Ocular Redness	evaluated prior to study medication instillation and at 5 minutes post instillation	up to 5 minutes post study medication instillation	No