Evaluation of the Safety and Effectiveness of the Bimatoprost Implant System / IOL Combination in Patients With Ocular Hypertension or Mild to Moderate Open-angle Glaucoma

A Prospective Trial to Evaluate the Safety and Effectiveness of the Sustained Release Bimatoprost Implant With SpyGlass IOL in Patients With Ocular Hypertension or Mild to Moderate Open-Angle Glaucoma

The goal of this clinical trial is to learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also learn about the safety of the Bimatoprost Implant System / IOL Combination. The main questions it aims to answer are:

• Does the Bimatoprost Implant System / IOL Combination lower the pressure inside the eye to treat ocular hypertension or glaucoma?
• Does the Bimatoprost Implant System / IOL Combination correct vision after cataract surgery?
• What medical problems do participants have when treated with the Bimatoprost Implant System / IOL Combination?

Participants will:

• Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated.
• Complete a baseline visit to further evaluate eligibility in the study eye.
• Undergo standard of care cataract surgery followed by implantation of the Bimatoprost Implant System / IOL Combination. Only one eye of each participant will be treated.
• Complete post-operative follow-up visits for evaluation at Day 1, Week 1, Month 1, Month 3, and Month 6 (last study visit).

This is a single center, proof-of-concept, nonrandomized, multi-arm, controlled clinical trial with a 6-month participation period. The study consists of 3 cohorts of up to 10 participants each. Participants are assigned sequentially to cohorts using a nonrandomized intervention model. Participants will receive standard-of-care cataract extraction by phacoemulsification followed by implantation of the SpyGlass Bimatoprost Implant System / IOL Combination (low-dose cohort; medium-dose cohort; and high-dose cohort). The primary endpoint was measured at 6 months. There was no masking in the study design, however, a 2-person reading method was used for all IOP measurements, wherein Observer 1 adjusts the dial and is masked to the reading on the dial and Observer 2 reads and records the value on the source documentation. Participants in this clinical study are seen for the following visits: a Screening visit, an Eligibility visit (Baseline), a Day 0 or Surgery visit, and postoperative visits at Day 1, Week 1, Month 1, Month 3, and Month 6 (Figure 1). Each participant has one eye designated as the study eye.

Inclusion Criteria:

• Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
• Planned removal of cataract
• Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension

Exclusion Criteria:

• Pregnant women as confirmed via urine pregnancy test for women of child-bearing age at screening
• History of incisional/refractive corneal surgery
• Pseudoexfoliation, pigmentary glaucoma, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders
• Other ocular diseases, pathology, or conditions