BTOS-HA for Red Eye

No longer recruiting at 13 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare a new eye drop treatment, Brimonidine Tartrate Ophthalmic Solution 0.025% with Sodium Hyaluronate (BTOS-HA), to Lumify for reducing red eyes. The goal is to determine if BTOS-HA is as effective at relieving eye redness. Participants should have previously used redness relief drops or wish to try them for ongoing eye redness issues. This trial may suit those dealing with red eyes and comfortable using eye drops independently. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop using certain medications before joining the trial. Specifically, you must stop using all eye-related medications like artificial tears and eye whiteners 5 days before, systemic antihistamines or decongestants 7 days before, and systemic corticosteroids or certain other medications 14 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Brimonidine Tartrate Ophthalmic Solution 0.025% with Sodium Hyaluronate is safe for reducing eye redness. Research indicates it effectively reduces redness for up to eight hours and maintains its effectiveness with repeated use.

The treatment is generally well-tolerated. Most reported side effects are mild, such as slight eye irritation or dryness, which are common with eye drops and usually resolve quickly. Overall, evidence suggests this treatment is safe for reducing eye redness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for red eye?

Researchers are excited about Brimonidine Tartrate Ophthalmic Solution with Sodium Hyaluronate (BTOS-HA) for treating red eye because it combines two powerful ingredients. Brimonidine tartrate works to reduce redness by constricting blood vessels, while sodium hyaluronate adds a moisturizing component that can soothe and hydrate the eyes. This dual action sets it apart from existing treatments that typically focus on reducing redness alone. Additionally, the presence of sodium hyaluronate may enhance comfort and potentially improve adherence to treatment compared to standard options.

What evidence suggests that BTOS-HA might be an effective treatment for red eye?

This trial will compare Brimonidine Tartrate Ophthalmic Solution 0.025% with Sodium Hyaluronate (BTOS-HA) to Brimonidine Tartrate Ophthalmic Solution 0.025% alone. Research has shown that BTOS-HA effectively reduces eye redness. Studies have found that BTOS-HA performs as well as Lumify, a product already approved for treating red eyes. Participants using BTOS-HA experienced a noticeable decrease in redness, similar to results with Lumify. The combination of Brimonidine and Sodium Hyaluronate not only reduces redness but also soothes the eyes. Overall, BTOS-HA is well-tolerated and matches Lumify in effectiveness. ^{1 3 4 6 7}

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06803654

NCT06803654 | A Study Comparing the Efficacy and ... A Randomized, Multicenter, Double-Masked, Active-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12370570/

A Multicenter Randomized Double-Masked Study ... Brimonidine tartrate ophthalmic solution 0.025% (LUMIFY® 0.025%) is the first selective α2-AR agonist approved to treat ocular redness [1]. As ...

3. go.drugbank.com go.drugbank.com/drugs/DB00484/clinical_trials?conditions=DBCOND0023338%2CDBCOND0023145&phase=3&purpose=treatment&status=completed

Brimonidine Completed Phase 3 Trials for Eye redness ... A Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Relative to Lumify in Adult Subjects ...

4. withpower.com withpower.com/trial/phase-3-erythema-2-2025-d1dbd

BTOS-HA for Red Eye · Info for Participants 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40711722/

A Multicenter Randomized Double-Masked Study ... Conclusions: BTOS-PF 0.025% was non-inferior to LUMIFY 0.025% in reducing ocular redness in adults, was well-tolerated, and offers an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5839712/

Brimonidine Ophthalmic Solution 0.025% for Reduction of ... Brimonidine 0.025% appeared safe and effective for reduction of ocular redness, with an 8-hour duration of action, no evidence of tachyphylaxis, and negligible ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35951740/

Brimonidine tartrate ophthalmic solution 0.025% for ... Clinical trials have so far shown that the drug in low doses significantly reduces ocular redness in comparison to vehicle for up to 8 hours.