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

RecruitingPhase 1, Phase 2Ages 40 Years - anyAllEyeD Pharma
NCT07036510 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 ฮฒ- 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.
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What it tests

  • TimoD implant
  • Injector system
  • Timolol eye drops 0.5%
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Where

1 site
Panama Eye Center
Panama City, Panama
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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