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
Summary
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 - ParticipantOcular Redness - Investigator
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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