Phase 3
Completed N=507
Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants
Hyperemia
Source: ClinicalTrials.gov NCT01959243 ↗
Enrolled (actual)
507
Serious AEs
0.4%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 66; 38; 44; 25 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
66; 38; 44; 25; 23; 16 | — |
| SECONDARY Drop Comfort Assessment as Assessed by the Participant |
0.4; 0.4; 0.4; 0.3; 0.4; 0.4 | — |
| SECONDARY Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 |
337; 170; 336; 169; 326; 167 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity;
- Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (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 Baseline (Visit 1) and for the duration of the study.
Data sourced from ClinicalTrials.gov (NCT01959243). 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.