Observational Study to Evaluate Long Term Outcomes for Ocular Hypertension and Glaucoma Patients Treated With the SpyGlass Bimatoprost Implant System / IOL Combination

NCT07154810 | Active Not Recruiting

• 1 other identifier: SGP-SPEC-004
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to further observe and learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also further observe and 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 continue lower the pressure inside the eye to treat ocular hypertension or glaucoma long term?
• Does the Bimatoprost Implant System / IOL Combination continue to correct vision after cataract surgery long term?
• What long term medical problems do participants have when treated with the Bimatoprost Implant System / IOL Combination?

Conditions

Glaucoma; Cataract; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Unmedicated eyes with an IOP Reduction from SGP-SPEC-001 Baseline

  The proportion of eyes that remain unmedicated and with an IOP reduction ≥ 20% from the SGP-SPEC-001 baseline visit for each follow-up time through the month 84 exam.

  From Month 9 post-operative through the end of post-operative follow-up at Month 84

Other Outcomes (6)

• Mean change in unmedicated IOP from SGP-SPEC-001 baseline visit for each follow-up time up to the month 84 exam.

  From Month 9 post-operative through the end of post-operative follow-up at Month 84

• Number of topical glaucoma medications used in the SGP-SPEC-001 screening for each follow-up time up to the month 84 examination

  From Month 9 post-operative through the end of post-operative follow-up at Month 84

• Assessment of Postoperative Adverse Events

  From Month 9 post-operative through the end of post-operative follow-up at Month 84

Study Arms (3)

Bimatoprost Implant System / IOL Combination Low Dose

Bimatoprost Implant System / IOL Combination Medium Dose

Bimatoprost Implant System / IOL Combination High Dose

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ocular hypertension or open-angle glaucoma participants in Honduras who completed the SpyGlass Pharma Inc. SGP-SPEC-001 study.

You may qualify if:

• Be able to understand a written informed consent and be willing to participate by evidence of signing an informed consent form

You may not qualify if:

• Planned participation in another clinical trial within 30 days of the initial study visit that, in the investigator's opinion, could confound the study results

Sponsors & Collaborators

• SpyGlass Pharma, Inc.: lead

Study Sites (1)

Centro Oftalmológico Robles

Santa Rosa de Copán, 41101, Honduras

Location

Related Publications (1)

• Tan NE, Katz G, Robles M, Gupta PK, Kahook MY, Sussman G, Yoo P, Radcliffe NM. Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results. Ophthalmol Ther. 2026 Feb 1. doi: 10.1007/s40123-026-01313-4. Online ahead of print.

  PMID: 41621045 DERIVED

MeSH Terms

Conditions

Glaucoma; Cataract; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases; Lens Diseases

Study Officials

• Sr. Director, Clinical Affairs

  SpyGlass Pharma, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 4, 2025
• Study Start: March 16, 2023
• Primary Completion (Estimated): April 14, 2031
• Study Completion (Estimated): April 14, 2031
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)