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Alpha-2 Adrenergic Agonist
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation for Red Eye
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
No Placebo-Only Group
Pivotal Trial
Approved for 5 Other Conditions
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation.
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 • NCT053607843%
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.
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.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used redness relief eye drops in the past 6 months or you want to use over-the-counter eye drops for redness relief.
Research Study Groups:
This trial has the following groups:- Group 1: Brimonidine tartrate preservation-free
- Group 2: Lumify®
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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