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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22+
SponsorSpyGlass Pharma, Inc.

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators