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

A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Adult and Geriatric Subjects With Ocular Redness

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.

Study Overview

• Status: Completed
• Conditions: Hyperemia
• Intervention / Treatment: Drug: Brimonidine Tartrate; Drug: Sodium Fluorescein; Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Bausch & Lomb Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brimonidine Tartrate; Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.	Drug: Brimonidine Tartrate; Ophthalmic solution to be applied as directed.; Drug: Sodium Fluorescein; For use as needed during the study for evaluating corneal damage.; Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP; For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.
Placebo Comparator: Brimonidine Tartrate Vehicle; 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.	Drug: Sodium Fluorescein; For use as needed during the study for evaluating corneal damage.; Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP; For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.; Drug: Vehicle; Ophthalmic solution to be applied as directed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale	Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness.	0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Redness as Measured by the Participant	Ocular redness was scored daily pre-dose and post-dose on Days 1 to 29 and scored daily on Days 30 to 36 by the participant using a 0 to 4 unit scale (not allowing half unit increments). A lower score was indicative of less redness. The LOCF method used for this Secondary Outcome Measure was for imputing missing daily post-dose mean scores for entire days. If ≥1 score was provided for a day, imputation was not done. Imputation was done within the dosing period and separately within the follow-up period. The average (mean) daily pre-dose and post-dose scores for the dosing period Day 1 to Day 15 and dosing period Day 15 to Day 29, and the average (mean) daily score for the follow-up period Day 29 to Day 36 are reported.	Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale	Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness.	0 (predose), 1, 360, and 480 minutes (min) postdose on Day 1 and 0 (predose), 1, and 5 min postdose on Days 15 and 29

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Collaborators: ORA, Inc.
• Investigators: Study Director: Heleen DeCory, Bausch & Lomb Incorporated

Publications and helpful links

General Publications

• McLaurin E, Cavet ME, Gomes PJ, Ciolino JB. Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular Redness: A Randomized Clinical Trial. Optom Vis Sci. 2018 Mar;95(3):264-271. doi: 10.1097/OPX.0000000000001182.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2013
• Primary Completion (Actual): December 20, 2013
• Study Completion (Actual): December 20, 2013

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 9, 2013

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Ocular redness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Manifestations; Erythema; Hyperemia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Pharmaceutical Solutions; Brimonidine Tartrate; Ophthalmic Solutions
• Other Study ID Numbers: 861