BTOS-HA for Red Eye

Recruiting at 4 trial locations

Overseen By Daniel Donatello

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bausch & Lomb Incorporated

Must be taking: Vasoconstrictors

Must not be taking: Ocular corticosteroids, Systemic corticosteroids

Disqualifiers: Ocular infection, Glaucoma, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

554 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

To demonstrate the efficacy of BTOS-HA as non inferior to Lumify for treating ocular redness in a population of adult subjects.

Are You a Good Fit for This Trial?

Adults who've used redness relief eye drops in the past 6 months or want to use them, can apply eye drops themselves, have good vision with correction if needed, and stable ocular health. They must not be pregnant or nursing and agree to follow trial instructions including visits.

Inclusion Criteria

Voluntarily provide written informed consent

I am 18 years old or older.

Able and willing to follow instructions, including participation in all trial assessments and visits

Exclusion Criteria

Prior or anticipated concurrent use of an investigational drug or device during the study period

Prior or currently active significant illness that could compromise participation, in the opinion of the investigator

I am not pregnant, nursing, or planning to become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brimonidine Tartrate Ophthalmic Solution 0.025% or BTOS-HA for treating ocular redness

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate

Trial Overview The study is testing BTOS-HA's effectiveness compared to Lumify for treating red eyes. It aims to show that BTOS-HA is just as good as Lumify in reducing eye redness among adults.

How Is the Trial Designed?

Group I: Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA) Experimental Treatment 1 Intervention

Group II: Brimonidine tartrate ophthalmic solution 0.025% Active Control 1 Intervention

Who Is Running the Clinical Trial?

Bausch & Lomb Incorporated

Lead Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University