Combining a bimatoprost eye implant with the SpyGlass intraocular lens versus timolol eye drops for people having cataract removal
Official 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%,
Run by SpyGlass Pharma, Inc. · NCT07218783 · Data updated 2026-11-12
This study will test whether placing a small bimatoprost implant with the SpyGlass intraocular lens at the time of cataract surgery better controls eye pressure than using timolol eye drops in people with mild to moderate open-angle glaucoma or ocular hypertension.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | SpyGlass Pharma, Inc. Industry-sponsored |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | March 31, 2029 |
| Study ends | March 31, 2031 |
| Registry record updated | October 20, 2025 |
| Trial ID | NCT07218783 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with mild to moderate open-angle glaucoma or ocular hypertension who are planning cataract removal and who meet pregnancy testing and contraception requirements for women of childbearing potential.
✕Probably not a fit
People with other glaucoma types, prior incisional glaucoma surgery or intraocular injections, prior incisional or refractive corneal surgery, uncontrolled systemic disease, or other significant ocular pathology are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized Phase 3 trial, participants with mild to moderate open-angle glaucoma or ocular hypertension who are scheduled for cataract removal are assigned to receive either a bimatoprost implant plus the SpyGlass IOL at the time of surgery or a commercial IOL with postoperative timolol eye drops. The trial compares safety and intraocular pressure control between the two approaches. Key outcomes include intraocular pressure reduction, need for additional glaucoma medications or procedures, and ocular safety events. The study is sponsored by SpyGlass Pharma and conducted at Houston Eye Associates.
Why it matters
Potential benefit: If successful, the combination could provide longer-lasting intraocular pressure control after cataract surgery and reduce reliance on daily eye drops.
How similar studies have gone: Previous trials of intracameral bimatoprost implants have shown IOP-lowering effects, but combining a bimatoprost implant specifically with an intraocular lens at cataract surgery is a newer approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Houston Eye Associates
Houston, Texas, United States Recruiting
Study contacts
- Study coordinator: Director, Clinical Affairs
- Email: clinical@spyglasspharma.com
- Phone: 949-284-6904
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.