Clinical Trial

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

Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
critical Phase changed: Phase 1 -> Phase 1/2 2026-07-31
critical Primary endpoint(s) modified 2026-07-31
notable Enrollment increased: 18 -> 42 participants 2026-07-31
minor Trial arms changed: 3 -> 4 2026-07-31
Trial Details
NCT Number NCT07036510
Lead Sponsor EyeD Pharma
Conditions Glaucoma, Ocular Hypertension
Enrollment 42 participants
Start Date 2025-06-12
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-30