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

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

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.

Clinical Details

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



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


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.

Locations and Contacts

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

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

Page last updated: August 20, 2015

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