Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation for Erythema

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Bausch Site 04, Colorado Springs, CO
Erythema+1 More
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the efficacy and safety of two eye drops for people with ocular redness. The Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation is being trialed for its efficacy in treating erythema. This particular formulation of the drug has previously been approved by the FDA for another condition, so none of the patients in the trial will be receiving a placebo.

Eligible Conditions

  • Erythema
  • Ocular Redness

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 4 hours after instillation

4 hours after instillation
Ocular redness

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Lumify®
1 of 2
Brimonidine tartrate preservation-free
1 of 2
Active Control
Experimental Treatment

386 Total Participants · 2 Treatment Groups

Primary Treatment: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation · No Placebo Group · Phase 3

Brimonidine tartrate preservation-free
Drug
Experimental Group · 1 Intervention: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation · Intervention Types: Drug
Lumify®
Drug
ActiveComparator Group · 1 Intervention: Lumify® (brimonidine tartrate ophthalmic solution 0.025%) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 hours after instillation
Closest Location: Bausch Site 04 · Colorado Springs, CO
Photo of colorado 1Photo of colorado 2Photo of colorado 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Erythema
0 CompletedClinical Trials

Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
231 Previous Clinical Trials
53,541 Total Patients Enrolled
1 Trials studying Erythema
60 Patients Enrolled for Erythema
Daniel DonatelloStudy DirectorBausch & Lomb Incorporated
3 Previous Clinical Trials
1,294 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years of age.
You are willing and able to follow all instructions and attend all study visits.
You are able to self-administer eye drops satisfactorily or have a subject's care provider at home.
At Visit 1 (Baseline), show a baseline redness score >1 unit (ie, greater than 1 unit) in both eyes on a 0 to 4 unit scale as scored by the Investigator using the Investigator Ocular Redness Scale.
You are male and with female partner of childbearing potential.
You are of childbearing potential and agree to have urine pregnancy testing performed at Visit 1 (must be negative) and at exit visit; must not be lactating; and must agree to use at least 1 medically acceptable form of birth control2 throughout the study duration and for at least 14 days prior to the first dose of study drug (Visit 1) and for 1 month after the last dose of investigational drug.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.