Bimatoprost implant with SpyGlass intraocular lens vs timolol drops for cataract patients with glaucoma
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. · NCT07218796 · Data updated 2026-11-12
This study tests whether placing a bimatoprost implant together with a SpyGlass intraocular lens during cataract surgery controls eye pressure better than daily timolol 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 (San Antonio, Texas) |
| Status | Recruiting |
| Started | October 28, 2025 |
| Main results expected | May 31, 2029 |
| Study ends | May 31, 2031 |
| Registry record updated | October 20, 2025 |
| Trial ID | NCT07218796 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with mild to moderate open‑angle glaucoma or ocular hypertension who are scheduled for cataract removal and meet the study's other inclusion and safety criteria.
✕Probably not a fit
Patients with other glaucoma types, a history of incisional glaucoma surgery or intraocular injections, prior corneal refractive surgery, uncontrolled systemic disease, or other significant ocular pathology are unlikely to qualify or benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 randomized trial enrolls participants with mild to moderate open‑angle glaucoma or ocular hypertension who are undergoing cataract removal. Participants are randomized to receive a SpyGlass intraocular lens plus a bimatoprost implant at the time of cataract surgery, or a commercial intraocular lens with postoperative timolol 0.5% ophthalmic solution. Investigators will follow participants at scheduled visits to measure intraocular pressure, monitor ocular health, and record adverse events. The study directly compares safety and duration of IOP control between the implant‑plus‑IOL approach and standard topical timolol therapy.
Why it matters
Potential benefit: If successful, the implant combined with the SpyGlass IOL could provide longer‑lasting intraocular pressure control and reduce or eliminate the need for daily glaucoma eye drops.
How similar studies have gone: Prior studies of intracameral bimatoprost implants have demonstrated IOP‑lowering effects, but combining an implant with the SpyGlass IOL during cataract surgery is a novel combination that has not been widely tested.
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
-
R and R Eye Research, LLC
San Antonio, 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.