Recruiting

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

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…

ClinicalTrials.gov IDNCT07036510

PhasePHASE1, PHASE2

Enrollment42

SponsorEyeD Pharma

Age40 Years

SexALL

I'm interested View official listing

Conditions studied

Glaucoma, Ocular Hypertension

About this study

Interventions

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.
Drug: 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

Primary outcomes

Stage 1: Number (%) of participants experiencing adverse events (From Screening (up to Day -41) to end of stage 1 (Month 13))
Stage 1: Number (%) of participants experiencing adverse events of special interest (AESI) (From Screening (up to Day -41) to end of stage 1 (Month 13))
Stage 2: Proportion of responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM IOP) (Month 3)
Stage 2: Proportion of time-matched responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM and 10 AM) (Month 3)

Eligibility information

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.

Study locations

Panama Eye Center, Panama City, Panama

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.