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Safety of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery
Sponsor: EyeD Pharma
Summary
The goal of this clinical trial is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma or ocular hypertension and requiring cataract surgery. The main questions it aims to answer are how safe are three different doses of the investigational drug is and how the body tolerates it. The study will also check: * how safely the implant is placed in and removed from the eye and how the body responds to the procedure, * if and the amount of Timolol released in the bloodstream, * if there is any positive effect on the pressure inside the eye.
Official title: Early Feasibility, Open-Label, Dose-Escalating, Non-Randomized Study to Evaluate the Safety of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2025-06-12
Completion Date
2027-01
Last Updated
2025-06-25
Healthy Volunteers
No
Conditions
Interventions
TimoD implant
Consists of 1 TimoD implant administration in the study eye.
Injector system
This is a CE-marked injector intended for intraocular lens (IOL) delivery. In this study, the injector is used as an"intraocular implant injection system" outside of its scope of intended use.
Locations (1)
Panama Eye Center
Panama City, Panama