BL1107 Eye Drops for Glaucoma

Recruiting at 7 trial locations

Overseen By Johnson Varughese

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bausch & Lomb Incorporated

Disqualifiers: Orthostatic hypotension, Active ocular disease, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

228 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new eye drops, BL1107, to determine their effectiveness for individuals with primary open-angle glaucoma or ocular hypertension (high eye pressure). The study compares different doses of BL1107 to Timolol, a standard treatment, to identify which is more effective. It suits those diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes. Participants should not have other eye diseases, plan to wear contact lenses during the study, or experience blood pressure drops when standing. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that BL1107 eye drops are currently undergoing testing to determine their safety for human use. This study is a Phase 2 trial, indicating that BL1107 has already been tested in a smaller group for safety and is now being evaluated in a larger group to assess its effectiveness. Specific information on how well participants tolerate BL1107 or any potential side effects is not yet available. However, since it is being compared to Timolol, a medication already approved for eye conditions, researchers likely have sufficient confidence in BL1107's safety to proceed with testing.

In this trial, some participants will receive a low dose of BL1107, while others will receive a high dose. By comparing these doses, the study aims to identify the safest and most effective amount of BL1107. This careful approach helps minimize risks and maximize benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BL1107 Eye Drops for glaucoma because they offer a novel approach to treating this condition. Unlike the standard treatment options, like Timolol, which primarily work by reducing fluid production in the eye, BL1107 Eye Drops are designed to improve fluid drainage. This new mechanism of action could potentially lower intraocular pressure more effectively. Additionally, the trial is exploring both low and high doses of BL1107, which may provide flexibility in treatment and improve outcomes for different patients.

What evidence suggests that this trial's treatments could be effective for glaucoma?

This trial will compare BL1107 eye drops with Timolol to assess their effectiveness in lowering eye pressure in individuals with primary open-angle glaucoma or high eye pressure. Research shows that BL1107 eye drops are designed to reduce eye pressure. Although specific data on BL1107 is limited, similar treatments have shown promise in managing these conditions. Participants in this trial may receive either a low or high dose of BL1107. Timolol, a well-known treatment used for comparison, effectively lowers eye pressure by reducing fluid in the eye. This trial aims to determine if BL1107 can perform as well as or better than Timolol. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults with primary open-angle glaucoma or ocular hypertension in both eyes may participate. Specific details on other inclusion or exclusion criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I have high eye pressure or open-angle glaucoma in both eyes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BL1107 or Timolol for 28 days in a double-masked, parallel comparison

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BL1107 Eye Drops
• Timolol

Trial Overview This Phase 2 trial is testing BL1107 eye drops at two different doses against Timolol maleate (0.5%), a standard treatment for glaucoma. The goal is to compare their effectiveness and safety in treating adults with glaucoma or high eye pressure.

How Is the Trial Designed?

Group I: BL1107 Low dose Experimental Treatment 1 Intervention

Group II: BL1107 High dose Experimental Treatment 1 Intervention

Group III: Timolol maleate 0.5% 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/NCT07168902

Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults ... This study will evaluate the safety and efficacy of BL1107 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This ...

2. sigma.larvol.com sigma.larvol.com/disease.php?e1=18856&e2=&DiseaseId=18856&tab=DiseaseOTT&sr=now&er=1+month&ipwnd=on&rlink=,DiseaseId=18856,tab=DiseaseOTT&rflag=1&page=2

Glaucoma Trials ... This study will evaluate and confirm that the efficacy and tolerability of aNew Preservative-free Generic Formulation of Travoprost 40μg/ml Eye Drops ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12278128/

Real-world outcomes of selective laser trabeculoplasty and ... Between January 2012 and January 2022, 4564 eyes of 2708 patients met study criteria with an average follow-up duration of 5 (SD 2.4) years. For ...

4. glaucoma.org glaucoma.org/articles/making-glaucoma-treatment-even-easier-with-sustained-release-medication

Making Glaucoma Treatment Even Easier With Sustained ... They found that iDose TR lowered eye pressure by 6.6 to 8.5 mmHg over 12 weeks, compared to the pressure before the implant. The timolol control ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12111932/

Two-Year Outcome of Selective Laser Trabeculoplasty for ... In the first-line group, the mean IOP dropped from 16.7 ± 2.3 mmHg to 13.7 ± 2.4 mmHg at two years post-treatment, reflecting a 16.8% reduction.

6. ctv.veeva.com ctv.veeva.com/study/phase-2-study-of-bl1107-eye-drops-vs-timolol-in-adults-with-primary-open-angle-glaucoma-or-ocular-h

Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With ... This study will evaluate the safety and efficacy of BL1107 in adults with primary open-angle glaucoma or ocular hypertension in both eyes.

7. adisinsight.springer.com adisinsight.springer.com/trials/700386417

A Phase 2 Evaluation of the Safety, Ocular Tolerability, and ... Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension.

8. glaucomafoundation.org glaucomafoundation.org/preservative-free-glaucoma-eye-drops/

Preservative-Free Glaucoma Eye Drops In fact, the prolonged use of eye drops preserved with BAK is a strong risk factor for ocular surface disease in patients with glaucoma. And ...