Bimatoprost Implant + SpyGlass Lens for Glaucoma/Ocular Hypertension
(Tigris Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new treatment using the Bimatoprost Implant (a type of eye implant) combined with a special lens called SpyGlass can benefit individuals with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery. Researchers are comparing two different doses of this new treatment against a standard eye drop, Timolol, to identify the most effective option. Individuals with open-angle glaucoma or high eye pressure who plan to have cataract surgery might be suitable candidates for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in eye care.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the Bimatoprost Implant System is generally safe for people. Studies indicate that both high and low doses of the implant effectively lower eye pressure in patients with open-angle glaucoma or high eye pressure. The implants have been safely used for up to a year, often reducing the need for other treatments to lower eye pressure.
For the high dose, earlier studies found that a single implant was safe and effective in reducing eye pressure for a long time. The low dose also showed similar results, with patients experiencing a significant drop in eye pressure and good tolerance.
In summary, while the current trial is in its early stages, previous studies provide promising evidence about the safety of the Bimatoprost Implant System in managing eye pressure.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the Bimatoprost Implant System for glaucoma and ocular hypertension because it offers a novel approach by delivering medication directly within the eye through an implant. Unlike traditional eye drops like Timolol Maleate, which require daily application and can be difficult for some patients to use consistently, the implant provides a steady release of medication over time, potentially improving adherence and effectiveness. Additionally, the implant’s use of Bimatoprost, a prostaglandin analog, targets fluid buildup in the eye to lower intraocular pressure, which is crucial in managing these conditions. This innovative delivery method could reduce the burden of daily medication and enhance patient outcomes.
What evidence suggests that this trial's treatments could be effective for glaucoma or ocular hypertension?
Research has shown that the Bimatoprost Implant System, in both high and low doses, effectively lowers eye pressure. In this trial, participants may receive either the high-dose or low-dose Bimatoprost Implant System combined with an intraocular lens (IOL). One study found that the implant significantly reduced eye pressure compared to a placebo, with an average difference of –1.53 mmHg. Another study found that some patients did not need any other treatments to lower eye pressure for up to 18 months after receiving the implant. The implant has also demonstrated effectiveness comparable to other treatments like laser therapy. These findings suggest that the Bimatoprost Implant could be a promising option for managing glaucoma and high eye pressure.12356
Who Is on the Research Team?
Chris Hafner
Principal Investigator
SpyGlass Pharma, Inc.
Are You a Good Fit for This Trial?
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
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 in combination with the SpyGlass IOL or Timolol 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 (High Dose)
- Bimatoprost Implant System (Low Dose)
- Timolol Maleate Ophthalmic Solution, 0.5%
Find a Clinic Near You
Who Is Running the Clinical Trial?
SpyGlass Pharma, Inc.
Lead Sponsor