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 | Completed

• 1 other identifier: SGP-SPEC-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Cataract; Ocular Hypertension; Glaucoma

Outcome Measures

Primary Outcomes (1)

• Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6

  The proportion of unmedicated eyes with IOP reduction of ≥ 20% from Baseline to the Month 6 exam.

  From Baseline until the end of post-operative follow-up at Month 6

Secondary Outcomes (2)

• Mean change in unmedicated IOP from Baseline to Month 6

  From Baseline until the end of post-operative follow-up at Month 6

• Number of topical glaucoma medications

  From Screening until the end of post-operative follow-up at Month 6

Other Outcomes (6)

• Adverse Events

  From Screening to the end of post-operative follow-up at Month 6

• Supplementary Safety Parameter - BCDVA

  From Screening to the end of post-operative follow-up at Month 6

• Supplementary Safety Parameter - Slit Lamp Examination

  From Screening to the end of post-operative follow-up at Month 6

Study Arms (3)

Bimatoprost Implant System / IOL Combination Low Dose

EXPERIMENTAL

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

Combination Product: Bimatoprost Implant System / IOL Combination

Bimatoprost Implant System / IOL Combination Medium Dose

EXPERIMENTAL

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

Combination Product: Bimatoprost Implant System / IOL Combination

Bimatoprost Implant System / IOL Combination High Dose

EXPERIMENTAL

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

Combination Product: Bimatoprost Implant System / IOL Combination

Interventions

Bimatoprost Implant System / IOL Combination COMBINATION_PRODUCT

Bimatoprost Implant System used in combination with the SpyGlass intraocular lens

Bimatoprost Implant System / IOL Combination High Dose; Bimatoprost Implant System / IOL Combination Low Dose; Bimatoprost Implant System / IOL Combination Medium Dose

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

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

Cataract; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Sr. Director, Clinical Affairs

  SpyGlass Pharma, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 4, 2025
• Study Start: April 21, 2022
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)