NCT06120842

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for phase_1

Timeline
18mo left

Started Oct 2023

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Oct 2023Nov 2027

Study Start

First participant enrolled

October 13, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Expected
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

November 1, 2023

Last Update Submit

August 21, 2025

Conditions

CataractGlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean IOP Reduction from Baseline (mmHg)

    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 Outcomes (6)

  • Mean IOP

    Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36

  • Mean IOP Change from Baseline

    Months 6, 12, 18, 24, 27, 30, 33, and 36

  • Time to postoperative introduction of IOP-lowering medications

    Total Study Period of 36 Months

  • Number of IOP-lowering medications introduced postoperatively

    Total Study Period of 36 Months

  • Proportion of eyes achieving BCDVA 20/40 or better

    Months 3, 6, and 12

  • +1 more secondary outcomes

Other Outcomes (1)

  • Number and Rates of Adverse Events

    Total Study Period of 36 Months

Study Arms (3)

Bimatoprost Implant System (High Dose) / IOL Combination

EXPERIMENTAL
Drug: Bimatoprost Implant System (High Dose)Device: SpyGlass IOL

Bimatoprost Implant System (Low Dose) / IOL Combination

EXPERIMENTAL
Drug: Bimatoprost Implant System (Low Dose)Device: SpyGlass IOL

Timolol Maleate Ophthalmic Solution 0.5%

ACTIVE COMPARATOR
Drug: Timolol Maleate Ophthalmic Solution, 0.5%Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL

Interventions

Bimatoprost Implant System (High Dose)DRUG

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

Bimatoprost Implant System (High Dose) / IOL Combination
Bimatoprost Implant System (Low Dose)DRUG

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

Bimatoprost Implant System (Low Dose) / IOL Combination
Timolol Maleate Ophthalmic Solution, 0.5%DRUG

Timolol Maleate Ophthalmic Solution 0.5% BID

Timolol Maleate Ophthalmic Solution 0.5%
Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOLDEVICE

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Timolol Maleate Ophthalmic Solution 0.5%
SpyGlass IOLDEVICE

SpyGlass Intraocular Lens

Bimatoprost Implant System (High Dose) / IOL CombinationBimatoprost Implant System (Low Dose) / IOL Combination

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Advanced Eye Research Institute

Glendale, Arizona, 85306, United States

Location

Related Links

MeSH Terms

Conditions

CataractGlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Chris Hafner

    SpyGlass Pharma, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 7, 2023

Study Start

October 13, 2023

Primary Completion

January 31, 2025

Study Completion (Estimated)

November 1, 2027

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations

US(1)