Recruiting
Phase 3

Bimatoprost & Timolol

Sponsor:

SpyGlass Pharma, Inc.

Code:

NCT07218783

Conditions

Cataract

Glaucoma

Ocular Hypertension

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Bimatoprost Implant System

SpyGlass IOL

Timolol Maleate Ophthalmic Solution, 0.5%

Commercial IOL

Study Details

Brief summary:

This trial is a randomized study to evaluate 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.

Conditions

Cataract

Glaucoma

Ocular Hypertension

Study ID

NCT07218783

Start date

Oct 15, 2025

Status verified date

Oct, 2025

Completion date

Mar 31, 2031

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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, pseudoexfoliative, or pigmentary glaucoma
  • History of incisional glaucoma surgery or intraocular injections
  • Other ocular diseases, pathology, or conditions

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bimatoprost Implant System / IOL Combination

active comparator: Timolol Maleate Ophthalmic Solution 0.5%

Interventions

Bimatoprost Implant System

Bimatoprost Implant System used in combination with the SpyGlass IOL

SpyGlass IOL

SpyGlass Intraocular Lens

Timolol Maleate Ophthalmic Solution, 0.5%

Timolol Maleate Ophthalmic Solution, 0.5% BID

Commercial IOL

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Primary outcome measure

  • Mean IOP Reduction from Baseline (mmHg) [ Time Frame: Weeks 2 and 6, and Month 3 ]
  • BCDVA 20/40 or better [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Director, Clinical Affairs

949-284-6904clinical@spyglasspharma.com

Locations

Houston Eye Associates

Recruiting

Houston, Texas, United States, 77025

Contacts

Clinical Research Coordinator

832-553-7100jmaguilar@houstoneye.com

More Information

Sponsor

SpyGlass Pharma, Inc.

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SpyGlass Pharma, Inc. on 2025-10-20.