Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)

A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07218796

Enrollment

400

Registered

2025-10-20

Start date

2025-10-28

Completion date

2031-05-31

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Glaucoma, Ocular Hypertension

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.

Interventions

DRUGBimatoprost Implant System

Bimatoprost Implant System used in combination with the SpyGlass IOL

DEVICESpyGlass IOL

SpyGlass Intraocular Lens

DRUGTimolol Maleate Ophthalmic Solution, 0.5%

Timolol Maleate Ophthalmic Solution, 0.5% BID

DEVICECommercial IOL

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean IOP Reduction from Baseline (mmHg)	Weeks 2 and 6, and Month 3	Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints
BCDVA 20/40 or better	Month 6	Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better

Secondary

Measure	Time frame	Description
Mean IOP Reduction from Baseline (mmHg)	Month 6, 9 and 12	Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints

Countries

United States

Contacts

Primary ContactDirector, Clinical Affairs

clinical@spyglasspharma.com949-284-6904

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026