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

NCT ID: NCT07154797

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-21
• Study Completion Date: 2022-12-13

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.

Conditions

Cataract; Ocular Hypertension; Glaucoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bimatoprost Implant System / IOL Combination Low Dose

Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass Intraocular Lens

Group Type: EXPERIMENTAL

Bimatoprost Implant System / IOL Combination

Intervention Type: COMBINATION_PRODUCT

Bimatoprost Implant System used in combination with the SpyGlass intraocular lens

Bimatoprost Implant System / IOL Combination Medium Dose

Bimatoprost Implant System (Medium Dose) used in combination with the SpyGlass Intraocular Lens

Group Type: EXPERIMENTAL

Bimatoprost Implant System / IOL Combination

Intervention Type: COMBINATION_PRODUCT

Bimatoprost Implant System used in combination with the SpyGlass intraocular lens

Bimatoprost Implant System / IOL Combination High Dose

Bimatoprost Implant System (High Dose) used in combination with the SpyGlass Intraocular Lens

Group Type: EXPERIMENTAL

Bimatoprost Implant System / IOL Combination

Intervention Type: COMBINATION_PRODUCT

Bimatoprost Implant System used in combination with the SpyGlass intraocular lens

Interventions

Bimatoprost Implant System / IOL Combination

Bimatoprost Implant System used in combination with the SpyGlass intraocular lens

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SpyGlass Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Director, Clinical Affairs

Role: STUDY_CHAIR

SpyGlass Pharma, Inc.

Locations

Centro Oftalmológico Robles

Santa Rosa de Copán, , Honduras

Countries

Honduras

Other Identifiers

SGP-SPEC-001

Identifier Type: -

Identifier Source: org_study_id