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Alpha-2 Adrenergic Agonist

"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"

Phase 3
Waitlist Available
Research Sponsored by Bausch & Lomb Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation.
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing two types of eye drops to see which one is better at reducing eye redness. It involves people who have red eyes and works by shrinking the blood vessels in their eyes to make them look less red.

Eligible Conditions
  • Red Eye

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ocular Redness

Side effects data

From 2022 Phase 3 trial • 380 Patients • NCT05360784
3%
Sinusitis
3%
Instillation site pain
2%
Visual acuity reduced
1%
Sepsis
1%
Covid 19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumify®
Brimonidine Tartrate Preservation-free

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Brimonidine tartrate preservation-freeExperimental Treatment1 Intervention
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Group II: Lumify®Active Control1 Intervention
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brimonidine
FDA approved

Find a Location

Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
257 Previous Clinical Trials
57,850 Total Patients Enrolled
Daniel DonatelloStudy DirectorBausch & Lomb Incorporated
4 Previous Clinical Trials
1,588 Total Patients Enrolled

Media Library

Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05360784 — Phase 3
Red Eye Research Study Groups: Brimonidine tartrate preservation-free, Lumify®
Red Eye Clinical Trial 2023: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation Highlights & Side Effects. Trial Name: NCT05360784 — Phase 3
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05360784 — Phase 3
~106 spots leftby Dec 2025
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