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

Condition(s) targeted: Hyperemia

Intervention: Brimonidine Tartrate (Drug); Vehicle (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Quintus Ngumah, OD, PhD, Study Director, Affiliation: Bausch & Lomb Incorporated

To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0. 025% versus its vehicle in a population of pediatric, adult, and geriatric subjects. At least 51% of subjects will be 40 years of age or older.

Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% in a Population of Pediatric, Adult, and Geriatric Subjects.

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Adverse Events

Secondary outcome:

Drop Comfort

Alertness

Minimum age: 5 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participants must be at least 5 years of age at Visit 1 of either sex gender and any

race or ethnicity;

- Have ocular health within normal limits, including a calculated best- corrected (if

necessary) visual acuity of 0. 3 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 Visit 1 and

for the duration of the study.

Bausch & Lomb Incorporated, Bridgewater, New Jersey 08807, United States

Starting date: February 2014
Last updated: July 24, 2014