Safety of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40+
SponsorEyeD Pharma
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
TimoD implant
DrugConsists of 1 TimoD implant administration in the study eye.
Injector system
DeviceThis 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.
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: TimoD implant - Dose 1 (low dose)Experimental treatment 2 interventions
Group B: TimoD implant - Dose 2 (intermediate dose)Experimental treatment 2 interventions
Group C: TimoD implant - Dose 3 (high dose)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number (%) of participants experiencing adverse events
Time frame
From Screening (up to Day -41) to end of study (Month 13)2
Number (%) of participants experiencing adverse events of special interest (AESI)
Time frame
From Screening (up to Day -41) to end of study (Month 13)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov