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NCT Number: NCT07218783

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

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.

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Key information

Conditions

Cataract Eye Diseases Glaucoma Lens Diseases Ocular Hypertension

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Houston Eye Associates

Houston, Texas, 77025, United States

Location status: Recruiting

Location contact

Clinical Research Coordinator

CONTACT

[email protected]

832-553-7100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bimatoprost Implant System

Drug

Bimatoprost Implant System used in combination with the SpyGlass IOL

SpyGlass IOL

Device

SpyGlass Intraocular Lens

Timolol Maleate Ophthalmic Solution, 0.5%

Drug

Timolol Maleate Ophthalmic Solution, 0.5% BID

Commercial IOL

Device

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Primary outcomes

  1. Mean IOP Reduction from Baseline (mmHg)

    Time frame: Weeks 2 and 6, and Month 3

    Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints

  2. BCDVA 20/40 or better

    Time frame: Month 6

    Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better

Secondary outcomes

  1. Mean IOP Reduction from Baseline (mmHg)

    Time frame: Month 6, 9 and 12

    Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints

Study contacts

Contact information is provided by the study sponsor or research team.

Director, Clinical Affairs

CONTACT

[email protected]

949-284-6904

Sponsors and collaborators

Lead sponsor

SpyGlass Pharma, Inc.

Industry

Registry information

Official study title

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%,

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Oct 20, 2025
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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