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Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects With Ocular Redness.

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 efficacy and safety of brimonidine tartrate ophthalmic solution 0. 025% with its vehicle for treating ocular redness in a population of adult and geriatric participants with ocular redness.

Clinical Details

Official title: Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Adult and Geriatric Subjects With Ocular Redness

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

Primary outcome: Ocular Redness - Investigator

Secondary outcome:

Ocular Redness - Participant

Ocular Redness - Investigator


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- At least 18 years of age.

- Have a history of redness relief drops use, or expressed a desire to use drops for

redness relief, within the last 6 months.

- Have ocular health within normal limits including a calculated best-corrected visual

acuity of 0. 3 logMAR or better in each eye, as measured using an ETDRS chart. Exclusion Criteria:

- Any ocular/systemic health problems.

- Use of any disallowed medications.

Locations and Contacts

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

Starting date: November 2013
Last updated: July 24, 2014

Page last updated: August 20, 2015

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