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

Not Applicable

Completed

• Conditions: Cataract; Ocular Hypertension; Glaucoma

• Registration Number: NCT07154797
• Lead Sponsor: SpyGlass Pharma, Inc.

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2022-04-21
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Status Verified: 2025-08
• Study First Submitted: 2025-08-22
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6	From Baseline until the end of post-operative follow-up at Month 6	The proportion of unmedicated eyes with IOP reduction of ≥ 20% from Baseline to the Month 6 exam.

Secondary Outcome Measures

Name	Time	Method
Mean change in unmedicated IOP from Baseline to Month 6	From Baseline until the end of post-operative follow-up at Month 6	Mean change in unmedicated IOP (mmHg) from Baseline to Month 6
Number of topical glaucoma medications	From Screening until the end of post-operative follow-up at Month 6	Number of topical glaucoma medications used at Screening compared to Month 6

Trial Locations

Locations (1)

Centro Oftalmológico Robles; 🇭🇳 Santa Rosa de Copán, Honduras