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

Phase 3

Completed

• Conditions: Hyperemia
• Interventions: Drug: Vehicle; Drug: Brimonidine Tartrate; Drug: Sodium Fluorescein; Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP

• Registration Number: NCT01959243
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-09
• Study Start: 2014-02-22
• Primary Completion: 2014-04-23
• Study Completion: 2014-06-23
• Status Verified: 2019-09
• Results First Submitted: 2019-10-01
• Results First Submitted QC: 2019-10-01
• Last Update Submitted: 2019-10-01
• Results First Posted: 2019-10-23
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 507

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brimonidine Tartrate Vehicle	Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP	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.
Brimonidine Tartrate Vehicle	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.
Brimonidine Tartrate	Sodium Fluorescein	Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
Brimonidine Tartrate	Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP	Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
Brimonidine Tartrate Vehicle	Sodium Fluorescein	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.
Brimonidine Tartrate	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	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 Outcome Measures

Name	Time	Method
Drop Comfort Assessment as Assessed by the Participant	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	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.

Trial Locations

Locations (4)

Bausch Site 3; 🇺🇸 Phoenix, Arizona, United States

Bausch Site 2; 🇺🇸 Philadelphia, Pennsylvania, United States

Bausch Site 1; 🇺🇸 Andover, Massachusetts, United States

Bausch Site 4; 🇺🇸 Havre De Grace, Maryland, United States