Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

SpyGlass Pharma, Inc.

Conditions:

Cataract

Glaucoma

Eligibility:

All Genders

22+ years

Phase:

PHASE1

PHASE2

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 13 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2027

Estimated Enrollment :

201 Patients enrolled

Trial Details

Trial ID

NCT06120842

Start Date

October 13 2023

End Date

November 1 2027

Last Update

August 22 2025

Active Locations (1)

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Arizona Advanced Eye Research Institute

Glendale, Arizona, United States, 85306