Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)

NCT07218783Phase 3Recruiting

Lead sponsor
SpyGlass Pharma, Inc. (Industry)
Enrollment
400 (estimated)
Start date
15 Oct 2025
Primary completion
31 Mar 2029 (estimated)
Study completion
31 Mar 2031
Last update posted
20 Oct 2025

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Double
Arms
2

Interventions

  • Bimatoprost Implant System Drug
  • SpyGlass IOL Device
  • Timolol Maleate Ophthalmic Solution, 0.5% Drug
  • Commercial IOL Device

Conditions and primary outcome

  • Cataract
  • Glaucoma
  • Ocular Hypertension

Primary outcome

Mean IOP Reduction from Baseline (mmHg) (Weeks 2 and 6, and Month 3); BCDVA 20/40 or better (Month 6)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT07218783.

CT-VCA trial quality

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Data integrity

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Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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