NCT07218796 Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)
| NCT ID | NCT07218796 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | SpyGlass Pharma, Inc. |
| Condition | Cataract |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-10-28 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Paul Yoo, OD
STUDY CHAIR
SpyGlass Pharma
Frequently Asked Questions
Who can join the NCT07218796 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07218796 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT07218796 currently recruiting?
Yes, NCT07218796 is actively recruiting participants. Contact the research team at clinical@spyglasspharma.com for enrollment information.
Where is the NCT07218796 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT07218796 clinical trial?
NCT07218796 is sponsored by SpyGlass Pharma, Inc.. The principal investigator is Paul Yoo, OD at SpyGlass Pharma. The trial plans to enroll 400 participants.