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 groupsSponsors and collaborators
Source ClinicalTrials.gov