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

Hyperemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959243
• Other study ID #: 862
• Status: Completed
• Phase: Phase 3
• Start date: February 22, 2014
• Est. completion date: June 23, 2014

Study information

• Verified date: September 2019
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: June 23, 2014
• Est. primary completion date: April 23, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperemia

Intervention

Drug:
• Brimonidine Tartrate
Ophthalmic solution to be applied as directed.
• Vehicle
Ophthalmic solution to be applied as directed.
• Sodium Fluorescein
For use as needed during the study for evaluating corneal damage.
• Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Locations

Country	Name	City	State
United States	Bausch Site 1	Andover	Massachusetts
United States	Bausch Site 4	Havre De Grace	Maryland
United States	Bausch Site 2	Philadelphia	Pennsylvania
United States	Bausch Site 3	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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