5 and older, any sex, with Hyperemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)Primary· Baseline up to Day 29
TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and require
Participants with at Least 1 TEAE
Group
Value
95% CI
Brimonidine Tartrate
66
Brimonidine Tartrate Vehicle
38
Participants with at Least 1 Ocular TEAE
Group
Value
95% CI
Brimonidine Tartrate
44
Brimonidine Tartrate Vehicle
25
Participants with at least 1 Non-Ocular TEAE
Group
Value
95% CI
Brimonidine Tartrate
23
Brimonidine Tartrate Vehicle
16
Participants with at least 1 Serious TEAE
Group
Value
95% CI
Brimonidine Tartrate
2
Brimonidine Tartrate Vehicle
0
Participants Discontinued from Study due to TEAEs
Group
Value
95% CI
Brimonidine Tartrate
5
Brimonidine Tartrate Vehicle
2
Drop Comfort Assessment as Assessed by the ParticipantSecondary· At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1
Drop comfort assessment (0-10 unit scale in which a score of 0 denotes "very comfortable" and 10 is "very uncomfortable") was performed by the participant. Participant's average score across eyes at each time point were used for analysis.
Upon Dose Installation
Group
Value
95% CI
Brimonidine Tartrate
0.4
± 0.90
Brimonidine Tartrate Vehicle
0.4
± 0.77
30 Seconds Postdose Installation
Group
Value
95% CI
Brimonidine Tartrate
0.4
± 0.90
Brimonidine Tartrate Vehicle
0.3
± 0.85
1 Minute Postdose Installation
Group
Value
95% CI
Brimonidine Tartrate
0.4
± 0.83
Brimonidine Tartrate Vehicle
0.4
± 0.83
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29Secondary· Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29
An alertness evaluation was performed by the Investigator asking the participant and/or participant's parent/legal guardian (pediatric participants only) a few questions based on the previous week. Using those answers, along with his/her clinical opinion, the Investigator made an assessment of the participant's level of alertness using the following 6-point scale: fully alert, alert, lethargy, obtunded, stupor, or coma.
Predose Installation on Day 1
Group
Value
95% CI
Brimonidine Tartrate
337
Brimonidine Tartrate Vehicle
170
Postdose Installation on Day 1
Group
Value
95% CI
Brimonidine Tartrate
336
Brimonidine Tartrate Vehicle
169
Postdose Installation on Day 8
Group
Value
95% CI
Brimonidine Tartrate
326
Brimonidine Tartrate Vehicle
167
Postdose Installation on Day 15
Group
Value
95% CI
Brimonidine Tartrate
326
Brimonidine Tartrate Vehicle
166
Postdose Installation on Day 29
Group
Value
95% CI
Brimonidine Tartrate
323
Brimonidine Tartrate Vehicle
164
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to Day 29.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05001243 — Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients
· Phase 1
· unknown
NCT03760185 — Pupil Dilation for Treatment of IFIS
· Phase 2
· completed
NCT03591874 — Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease
· Phase 3
· terminated
NCT03785340 — Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)
· Phase 3
· completed
NCT03497442 — Treatment of Asian Flushing Syndrome With Topical Alpha Agonists
· EARLY_PHASE1
· completed
Other recruiting trials for Hyperemia
Currently open trials in the same condition.
NCT05706181 — Heat Therapy, Functional Capacity, and Vascular Health in Older Adults
· Phase 1, PHASE2
· recruiting
Other Bausch & Lomb Incorporated trials
Trials by the same sponsor.
NCT07054606 — A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear
· Phase 4
· completed
NCT06803654 — A Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Rel
· Phase 3
· completed
NCT06594185 — A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects
· NA
· completed
NCT06479148 — Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) Lens
· NA
· terminated
NCT06333028 — A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bausch & Lomb Incorporated
Last refreshed: 23 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01959243.