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Safety and Efficacy 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 study is conducted in two stages. The first stage (Stage 1/Phase 1) is intended to study the safety of 3 different doses of the study medication (called TimoD implant). The second stage (Stage 2/Phase 2) of the study is intended to study in greater detail the efficacy and safety of the 3 doses of the TimoD implant in comparison to a standard approved medication, timolol eye drops for 3 years.
Official title: Early Feasibility Study to Evaluate the Safety and Efficacy 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
42
Start Date
2025-06-12
Completion Date
2027-01
Last Updated
2026-07-30
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.
Timolol eye drops 0.5%
Timolol eye drops will be self-admnistered twice daily in the study eye approximately 12 hours apart throughout the study
Locations (1)
Panama Eye Center
Panama City, Panama