Phase 3
N=60
Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness
Hyperemia
Bottom Line
View on ClinicalTrials.gov: NCT01959230 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale — 1.82; 1.71; 0.58; 1.40 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brimonidine Tartrate (Drug); Vehicle (Drug); Sodium Fluorescein (Drug); Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale |
1.82; 1.71; 0.58; 1.40; 0.58; 1.35 | — |
| SECONDARY Ocular Redness as Measured by the Participant |
1.52; 1.83; 0.85; 1.85; 1.45; 1.59 | — |
| SECONDARY Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale |
1.82; 1.71; -1.06; -0.23; -0.78; -0.10 | — |
Summary
To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.
Eligibility 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 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Exclusion Criteria
- Any ocular/systemic health problems.
- Use of any disallowed medications.
Data sourced from ClinicalTrials.gov (NCT01959230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.