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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

NCT07154797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-04

No results posted yet for this study

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).

Conditions

Interventions

COMBINATION_PRODUCT

Bimatoprost Implant System / IOL Combination

Bimatoprost Implant System used in combination with the SpyGlass intraocular lens

Sponsors & Collaborators

  • SpyGlass Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Sr. Director, Clinical Affairs · SpyGlass Pharma, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2022-12-13
Completion
2022-12-13

Countries

  • Honduras

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154797 on ClinicalTrials.gov