Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants

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

To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.

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): 507
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Bausch Site 3
  • Maryland
    • Havre De Grace, Maryland, United States, 21078
      • Bausch Site 4
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Bausch Site 1
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19148
      • Bausch Site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity;
• Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.

Exclusion Criteria:

• Have any ocular/systemic health problems
• Use of any disallowed medications during the period indicated prior to Baseline (Visit 1) and for the duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section.	Baseline up to Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drop Comfort Assessment as Assessed by the Participant	Drop comfort assessment (0-10 unit scale in which a score of 0 denotes "very comfortable" and 10 is "very uncomfortable") was performed by the participant. Participant's average score across eyes at each time point were used for analysis.	At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29	An alertness evaluation was performed by the Investigator asking the participant and/or participant's parent/legal guardian (pediatric participants only) a few questions based on the previous week. Using those answers, along with his/her clinical opinion, the Investigator made an assessment of the participant's level of alertness using the following 6-point scale: fully alert, alert, lethargy, obtunded, stupor, or coma.	Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2014
• Primary Completion (Actual): April 23, 2014
• Study Completion (Actual): June 23, 2014

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 1, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Ocular redness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; 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: 862