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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 23, 2014

Interventions

  • Drug: Brimonidine Tartrate
    • Ophthalmic solution to be applied as directed.
  • Drug: Vehicle
    • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs)
    • Time Frame: Baseline up to Day 29
    • 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.

Secondary Measures

  • Drop Comfort Assessment as Assessed by the Participant
    • Time Frame: At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1
    • 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.
  • Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29
    • Time Frame: Predose installation on Day 1 and 90-180 minutes postdose installation 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bausch & Lomb Incorporated
  • Collaborator
    • ORA, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Heleen DeCory, Study Director, Bausch & Lomb Incorporated

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