Bimatoprost Implant + SpyGlass Lens for Glaucoma/Ocular Hypertension

(Tigris Trial)

Overseen By Chris Hafner

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: SpyGlass Pharma, Inc.

Disqualifiers: Uncontrolled systemic disease, other ocular diseases, others

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

Compensation: Varies

Number of Visits: 2

Duration: 36 months

201 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is a randomized study to evaluate and compare two doses of the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Bimatoprost Implant + SpyGlass Lens for Glaucoma/Ocular Hypertension?

Research shows that bimatoprost and timolol, when used together, effectively lower eye pressure in patients with glaucoma or ocular hypertension. Additionally, a study found that a higher dose of bimatoprost implant effectively reduces eye pressure compared to laser treatment in similar patients. ^{1 2 3 4 5}

How is the Bimatoprost Implant + SpyGlass Lens treatment for glaucoma different from other treatments?

The Bimatoprost Implant + SpyGlass Lens treatment is unique because it involves an implant that delivers medication directly inside the eye, potentially offering a more consistent and long-term reduction in eye pressure compared to traditional eye drops like Timolol Maleate, which are applied topically. ^{1 3 4 5 6}

Research Team

Chris Hafner

Principal Investigator

SpyGlass Pharma, Inc.

Eligibility Criteria

This trial is for adults with mild to moderate open-angle glaucoma or ocular hypertension who are also undergoing cataract surgery. Participants must not have other types of glaucoma, uncontrolled diseases, a history of certain eye surgeries, or additional eye conditions.

Inclusion Criteria

I am scheduled for cataract surgery.

I am a woman who can have children, not pregnant, and agree to use birth control.

I have been diagnosed with mild to moderate open-angle glaucoma or high eye pressure.

Exclusion Criteria

I have no other eye diseases or conditions.

I have had surgery for glaucoma or injections in my eye.

I have a disease that is not currently under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Bimatoprost Implant System in combination with the SpyGlass IOL or Timolol Ophthalmic Solution

36 months

Regular visits at Weeks 2 and 6, and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bimatoprost Implant System (High Dose)
• Bimatoprost Implant System (Low Dose)
• Timolol Maleate Ophthalmic Solution, 0.5%

Trial Overview The study compares two doses of the Bimatoprost Implant System combined with SpyGlass IOL against Timolol Ophthalmic Solution in patients having cataract surgery and living with specific types of glaucoma or high eye pressure.

Participant Groups

Group I: Bimatoprost Implant System (Low Dose) / IOL Combination Experimental Treatment 2 Interventions

Group II: Bimatoprost Implant System (High Dose) / IOL Combination Experimental Treatment 2 Interventions

Group III: Timolol Maleate Ophthalmic Solution 0.5% Active Control 2 Interventions

Who Is Running the Clinical Trial?

SpyGlass Pharma, Inc.

Lead Sponsor

Trials

1

Recruited

200+

Findings from Research

In a study of 606 patients with primary open-angle glaucoma or ocular hypertension, the fixed combination of bimatoprost 0.03% and timolol 0.5% significantly lowered intraocular pressure (IOP) from a baseline of 20.7 mmHg to 16.1 mmHg after 12 weeks, demonstrating a reduction of 22.2%.

The treatment was well tolerated, with 98.7% of physicians and 96.7% of patients rating its tolerability as excellent or good, and only a few adverse events were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study. Feuerhake, C., Buchholz, P., Kimmich, F.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomised, double masked, multicentre clinical trial comparing bimatoprost and timolol for the treatment of glaucoma and ocular hypertension. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Bimatoprost/timolol fixed combination: a 3-month double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension. [2015]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Bimatoprost/timolol: a review of its use in glaucoma and ocular hypertension. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Phase 3, Randomized Study Comparing Intracameral Bimatoprost Implant 15 µg and Selective Laser Trabeculectomy in Patients with Open-Angle Glaucoma or Ocular Hypertension. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Single Administration of Intracameral Bimatoprost Implant 10 µg in Patients with Open-Angle Glaucoma or Ocular Hypertension. [2022]