Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution (Tigris)

August 21, 2025 updated by: SpyGlass Pharma, Inc.

A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%

This trial is a randomized study to evaluate and compare two doses of the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Advanced Eye Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
  • Planned removal of cataract
  • Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception

Exclusion Criteria:

  • Uncontrolled systemic disease
  • History of incisional/refractive corneal surgery
  • Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliation, or pigmentary glaucoma
  • History of incisional glaucoma surgery or intraocular injections
  • Other ocular diseases, pathology, or conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bimatoprost Implant System (High Dose) / IOL Combination
Drug: Bimatoprost Implant System (High Dose)
Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL
Device: SpyGlass IOL
SpyGlass Intraocular Lens
Experimental: Bimatoprost Implant System (Low Dose) / IOL Combination
Device: SpyGlass IOL
SpyGlass Intraocular Lens
Drug: Bimatoprost Implant System (Low Dose)
Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL
Active Comparator: Timolol Maleate Ophthalmic Solution 0.5%
Drug: Timolol Maleate Ophthalmic Solution, 0.5%
Timolol Maleate Ophthalmic Solution 0.5% BID
Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean IOP Reduction from Baseline (mmHg)
Time Frame: Weeks 2 and 6, and Month 3
Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints
Weeks 2 and 6, and Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean IOP
Time Frame: Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Time matched mean IOP (mmHg) at Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Mean IOP Change from Baseline
Time Frame: Months 6, 12, 18, 24, 27, 30, 33, and 36
Time matched mean IOP change from Baseline (mmHg) at Months 6, 12, 18, 24, 27, 30, 33, and 36
Months 6, 12, 18, 24, 27, 30, 33, and 36
Time to postoperative introduction of IOP-lowering medications
Time Frame: Total Study Period of 36 Months
Time (Days) to postoperative introduction of IOP-lowering medications (IOP-lowering medications other than the study treatments)
Total Study Period of 36 Months
Number of IOP-lowering medications introduced postoperatively
Time Frame: Total Study Period of 36 Months
Number of IOP-lowering medications introduced postoperatively (N) at Weeks 2 and 6, and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Total Study Period of 36 Months
Proportion of eyes achieving BCDVA 20/40 or better
Time Frame: Months 3, 6, and 12
Snellen Equivalent
Months 3, 6, and 12
Manifest refraction spherical equivalent
Time Frame: Month 3
Manifest refraction spherical equivalent (MRSE)
Month 3

Other Outcome Measures

Outcome Measure
Time Frame
Number and Rates of Adverse Events
Time Frame: Total Study Period of 36 Months
Total Study Period of 36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SpyGlass Pharma, Inc.

Investigators

  • Study Chair: Chris Hafner, SpyGlass Pharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2023

Primary Completion (Actual)

January 31, 2025

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGP-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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