RecruitingPhase 1Phase 2NCT07036510

Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery

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

Sponsor

EyeD Pharma

Enrollment

42 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Glaucoma Ocular Hypertension

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.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety of a sustained-release eye implant called TimoD in patients with glaucoma or high eye pressure (ocular hypertension) who are also having cataract surgery. The implant is designed to lower eye pressure over time without daily eye drops. **You may be eligible if...** - You have open-angle glaucoma or elevated eye pressure - You have age-related cataracts and are scheduled for cataract surgery with lens implantation - You are in good general and mental health - You can provide informed consent **You may NOT be eligible if...** - You have certain other types of glaucoma - Your eye anatomy is not suitable for the implant - You have serious eye infections or uncontrolled inflammation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTimoD implant

Consists of 1 TimoD implant administration in the study eye.

DEVICEInjector 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.

DRUGTimolol eye drops 0.5%

Timolol eye drops will be self-admnistered twice daily in the study eye approximately 12 hours apart throughout the study