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Study of Bimatoprost Implant System with SpyGlass IOL for Glaucoma and Cataracts

This study is looking at the Bimatoprost Implant System combined with the SpyGlass Intraocular Lens (IOL) compared to Timolol Ophthalmic Solution for people with mild to moderate open-angle glaucoma or ocular hypertension (high eye pressure) who are also having cataract surgery. The study wants to see if the Bimatoprost Implant System and SpyGlass IOL can effectively lower eye pressure and improve vision. You may be able to join if you are at least 22 years old, have mild to moderate open-angle glaucoma or ocular hypertension, and are planning to have cataract surgery. The study will measure how much your eye pressure decreases and if your vision improves to 20/40 or better. The current status of this study is unclear.

Study design
This is a randomized study, meaning participants will be assigned by chance to receive either the Bimatoprost Implant System with SpyGlass IOL or Timolol Ophthalmic Solution with a standard IOL. The study plans to enroll 400 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your eye pressure will be measured at 2 and 6 weeks, and at 3 months. Your vision will be checked at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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)

Recruiting
PHASE3Ages 22+InterventionalTreatment
SpyGlass Pharma, Inc.
~400 participants
Updated 2025-10-20 on ClinicalTrials.gov
What's tested:Bimatoprost Implant SystemSpyGlass IOLTimolol Maleate Ophthalmic Solution, 0.5%Commercial IOL

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean IOP Reduction from Baseline (mmHg)
Measured over Weeks 2 and 6, and Month 3
+1 more outcome measured

Conditions

Cataract
Glaucoma
Ocular Hypertension

Explore related trials

CataractGlaucomaOcular Hypertension

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Paul Yoo, OD · STUDY_CHAIR · SpyGlass Pharma

Who to contact

Director, Clinical Affairs
[email protected]
949-284-6904
Email the study team

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Do you actually qualify for this trial?

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

What this trial measures

  • 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 betterMonth 6

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