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

Phase 3CompletedNCT01959243

Bausch & Lomb Incorporated507 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

507

Conditions

Hyperemia

Interventions

Brimonidine TartrateDRUG

Ophthalmic solution to be applied as directed.

VehicleDRUG

Ophthalmic solution to be applied as directed.

Sodium FluoresceinDRUG

For use as needed during the study for evaluating corneal damage.

Eligibility

Sex: ALLMin age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Bausch Site 3

Phoenix, Arizona, United States

Bausch Site 4

Havre de Grace, Maryland, United States

Bausch Site 1

Andover, Massachusetts, United States

Bausch Site 2

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline up to Day 29

Secondary Outcomes

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.

Time frame: 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.

Time frame: Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29

Data from ClinicalTrials.gov

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