BL1332 for Eye Health

Overseen By Celia Busby

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bausch & Lomb Incorporated

Must not be taking: Gabapentinoids, Opioids, NSAIDs, others

Disqualifiers: Pregnancy, Tobacco, Alcohol, others

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and tolerability of new eye drops called BL1332 ophthalmic solution. Researchers aim to determine the highest doses that people can use without issues. The trial compares different strengths of BL1332 drops to a placebo (inactive drops) to assess their effects on healthy eyes. Ideal participants have healthy eyes and vision of 20/40 or better in each eye. As a Phase 1 trial, participants will be among the first to receive this new treatment, helping researchers understand its effects in people.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications. The trial excludes participants who have used gabapentinoids, opioids, topical capsaicin, systemic corticosteroids, anticoagulants, migraine medications, or CYP3A4/CYP3A5 inhibitors or inducers within specific time frames before the study. Chronic use of medications that haven't been stable for at least 14 days before screening is also not allowed.

Is there any evidence suggesting that BL1332 ophthalmic solution is likely to be safe for humans?

In a previous study, researchers examined the safety of BL1332 eye drops, focusing on how well participants handled different strengths. They noted common side effects, including slight increases in eye pressure, redness, and minor bleeding in the eye, occurring in 1% to 6% of participants.

The study aimed to identify the highest safe dose by testing various amounts to determine which were safe without causing serious issues. Overall, most participants tolerated the treatment well, experiencing only mild side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BL1332 ophthalmic solution because it offers a new approach to eye health by providing multiple concentrations (0.06%, 0.15%, and 0.30%) that can be tailored to individual needs. Unlike traditional treatments like artificial tears or anti-inflammatory drops, BL1332 is designed as a topical ocular drop that may deliver targeted benefits directly to the eye surface. This could potentially improve comfort and efficacy for patients, with less systemic absorption and side effects compared to oral medications or invasive procedures.

What evidence suggests that BL1332 ophthalmic solution might be an effective treatment for eye health?

Research has shown that similar eye treatments improve eye health. For instance, studies have found that certain eye drops enhance overall corneal health and reduce eye discomfort. In this trial, researchers are testing BL1332 ophthalmic solution, administered in various concentrations, to determine its safety and tolerability in healthy eyes. Although specific results for BL1332 are not yet available, it is based on the success of similar treatments. This suggests that BL1332 might benefit eye health, but further research is needed. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy volunteers who are willing to test a new eye drop solution called BL1332. Participants should not have any ongoing eye conditions or be using other ocular medications that could interfere with the study.

Inclusion Criteria

Written informed consent prior to conduct of any study-related assessment

Vital signs within specified ranges at Screening and Baseline Visit

Body mass index (BMI) between 18.0 and 30.0 kg/m2

Exclusion Criteria

I regularly use pain relievers like acetaminophen or NSAIDs.

I am using eye drops for an ongoing eye condition.

Use of tobacco products within 3 months prior to Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ascending concentrations of topical BL1332 ophthalmic solution eye drops to assess safety and tolerability

Approximately 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BL1332 ophthalmic solution
• BL1332 ophthalmic vehicle

Trial Overview The study is testing different strengths of BL1332 eye drops against a placebo (vehicle) to find out which doses are safe and how they affect the body. It's an early-stage, single-center trial focusing on safety and dosage levels.

How Is the Trial Designed?

Group I: BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) Experimental Treatment 1 Intervention

BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) administered as topical ocular drops

Group II: BL1332 vehicle Placebo Group 1 Intervention

BL1332 vehicle administered as topical ocular drops

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. withpower.com withpower.com/trial/bl1332-for-eye-health-fa6e2

BL1332 for Eye Health · Info for Participants This trial is for healthy volunteers who are willing to test a new eye drop solution called BL1332. Participants should not have any ongoing eye conditions or ...

2. withpower.com withpower.com/t/bromday

Bromday: Everything you need to know | Power BL1332 for Eye Health. 18 - 50. All Sexes. Fair Lawn, NJ. This trial is testing the safety and tolerance of BL1332 eye drops on both the eyes and the body. They ...

3. pharmacytimes.com pharmacytimes.com/view/researchers-announce-safety-and-efficacy-for-an-ophthalmic-solution-to-treat-dry-eye-disease

Researchers Announce Safety and Efficacy of Ophthalmic ... The results from the phase 3 trial displayed enhancements in the total corneal fluorescein straining (tCFS) and the visual analog scale (VAS) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10672675/

The Efficacy and Safety of Rebamipide Ophthalmic ... In conclusion, this systematic review has demonstrated that REB ophthalmic suspension treatment achieves better results than the control groups.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10768324/

Two multicenter, randomized studies of the efficacy and ... The novel ophthalmic formulations CsA 0.05% and 0.1% were safe and effective in the treatment of moderate to severe dry eye disease yielding improvements.

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-safety-tolerability-and-pharmacokinetics-of-ascending-concentrations-of-topical

A Study to Assess Safety, Tolerability, and Pharmacokinetics ... Single-Center, Phase 1 study to assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2017/208144Orig1s000MedR.pdf

208144Orig1s000 | FDA The Integrated Summary of Safety data is based on the 426 subjects on drug and 209 on placebo enrolled in a total four clinical trials. Study 11 ...

8. abbvieeyecare.com abbvieeyecare.com/product-information

abbvie product information The most common adverse events were reported in 1% to 6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, ...