NCT06120842Active, not recruitingPhase 1/2
Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution
A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%
Source: ClinicalTrials.gov · Last updated 22 Aug 2025
Brief summary (registry, in English)
This trial is a randomized study to evaluate and compare two doses of 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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 201 (actual)
- First submitted
- 1 Nov 2023
- Start date
- 13 Oct 2023
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- SpyGlass Pharma, Inc.
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT06120842
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 201
- From 13 Oct 2023 to the primary completion date, 31 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled systemic disease
- History of incisional/refractive corneal surgery
- History of incisional glaucoma surgery or intraocular injections
- Other ocular diseases, pathology, or conditions
Other
- Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliation, or pigmentary glaucoma
Who the study is looking for
- 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
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arizona Advanced Eye Research Institute Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.