Phase 3
Completed N=60
Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness
Hyperemia
Source: ClinicalTrials.gov NCT01959230 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: 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
◆ Published Evidence
Established
29citations · ~4 / year
Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular Redness: A Randomized Clinical Trial.
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.
Linked Publications
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Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular Redness: A Randomized Clinical Trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.