Bimatoprost Implant System for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery. Researchers are testing a Bimatoprost Implant System (an eye implant) combined with the SpyGlass IOL against standard Timolol eye drops to determine which is more effective. Participants diagnosed with open-angle glaucoma or ocular hypertension who plan to have cataracts removed may be suitable for this study. As a Phase 3 trial, this study is the final step before FDA approval, allowing participants to contribute to the development of a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that the Bimatoprost Implant System safely lowers eye pressure in people with open-angle glaucoma. These studies indicate that the implant can reduce the need for other eye pressure-lowering medications for up to a year. Some side effects include changes in eye color and darkening of the eyelid.
The Timolol Ophthalmic Solution, another treatment compared in this trial, has FDA approval for lowering eye pressure in glaucoma patients. It is generally well-tolerated, though it can sometimes cause temporary stinging or burning in the eye.
Overall, past research has demonstrated that both treatments are safe and effective. However, individual experiences may vary, and discussing any concerns with a healthcare provider is always advisable.12345Why do researchers think this study treatment might be promising for glaucoma?
Unlike most glaucoma treatments that rely on daily eye drops, the Bimatoprost Implant System offers a unique delivery method by being directly implanted into the eye. This system provides a sustained release of medication, potentially reducing the need for frequent dosing and improving adherence to treatment. Researchers are excited about this approach because it targets the condition continuously and directly, which might enhance the effectiveness and convenience for patients compared to traditional methods like Timolol eye drops.
What evidence suggests that the Bimatoprost Implant System is effective for glaucoma?
Research shows that the Bimatoprost Implant System, a treatment under study in this trial, effectively lowers eye pressure in people with open-angle glaucoma. Studies have found that one implant can reduce eye pressure for up to a year, helping to protect the optic nerve and maintain vision. The implant matches the effectiveness of selective laser trabeculoplasty (SLT) in lowering eye pressure and can also reduce the need for other medications. These findings suggest that the Bimatoprost Implant System is a promising option for managing open-angle glaucoma. Participants in this trial may receive either the Bimatoprost Implant System or the Timolol Maleate Ophthalmic Solution, which serves as an active comparator.12467
Who Is on the Research Team?
Paul Yoo, OD
Principal Investigator
SpyGlass Pharma
Are You a Good Fit for This Trial?
This trial is for people with mild to moderate open-angle glaucoma or ocular hypertension who are also undergoing cataract surgery. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the Bimatoprost Implant System with SpyGlass IOL or Timolol Maleate Ophthalmic Solution
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bimatoprost Implant System
- Timolol Ophthalmic Solution
Find a Clinic Near You
Who Is Running the Clinical Trial?
SpyGlass Pharma, Inc.
Lead Sponsor