RECRUITINGPhase 1INTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Capable of giving signed willing to sign a consent form. - In good general and mental health without ongoing clinically significant abnormalities in medical history. - Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement. - successful, uncomplicated cataract surgery Who Should NOT Join This Trial: - Subjects with a history of hypersensitivity or contraindications to β- blockers. - Participants using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure - Significant risks caused by washout of ocular hypotensive medications. - Clinically significant ocular pathology other than OHT, glaucoma and cataract Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Capable of giving signed informed consent. * In good general and mental health without ongoing clinically significant abnormalities in medical history. * Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement. * successful, uncomplicated cataract surgery Exclusion Criteria: * Subjects with a history of hypersensitivity or contraindications to β- blockers. * Participants using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure * Significant risks caused by washout of ocular hypotensive medications. * Clinically significant ocular pathology other than OHT, glaucoma and cataract

Treatments Being Tested

DRUG

TimoD implant

Consists of 1 TimoD implant administration in the study eye.

DEVICE

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