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

NCT01959243 | Completed Phase 3 Results

• 1 other identifier: 862
• Study Type: interventional
• Target: 507
• Locations: 1 country
• Sites: 4

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.

Conditions

Hyperemia

Keywords

Ocular redness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Drop Comfort Assessment as Assessed by the Participant

  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

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

Study Arms (2)

Brimonidine Tartrate

EXPERIMENTAL

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; Drug: Sodium Fluorescein; Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP

Brimonidine Tartrate Vehicle

PLACEBO COMPARATOR

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: Vehicle; Drug: Sodium Fluorescein; Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP

Interventions

Brimonidine Tartrate DRUG

Ophthalmic solution to be applied as directed.

Brimonidine Tartrate

Vehicle DRUG

Ophthalmic solution to be applied as directed.

Brimonidine Tartrate Vehicle

Sodium Fluorescein DRUG

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

Brimonidine Tartrate; Brimonidine Tartrate Vehicle

Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP DRUG

For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Brimonidine Tartrate; Brimonidine Tartrate Vehicle

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead
• ORA, Inc.: collaborator

Study Sites (4)

Bausch Site 3

Phoenix, Arizona, 85032, United States

Location

Bausch Site 4

Havre de Grace, Maryland, 21078, United States

Location

Bausch Site 1

Andover, Massachusetts, 01810, United States

Location

Bausch Site 2

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

Hyperemia

Interventions

Brimonidine Tartrate; Fluorescein

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Polycyclic Compounds

Results Point of Contact

• Title: Director, Medical Affairs
• Organization: Bausch & Lomb Incorporated

Heleen.DeCory@bausch.com

Study Officials

• Heleen DeCory

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 9, 2013
• Study Start: February 22, 2014
• Primary Completion: April 23, 2014
• Study Completion: June 23, 2014
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-09

Locations

US (4)