Health Trials

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

ConditionsGlaucomaOcular Hypertension
Trial statusRecruiting
Trial phasePhase 1, Phase 2
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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

    Drug

    Consists of 1 TimoD implant administration in the study eye.

  • Injector system

    Device

    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.

  • Timolol eye drops 0.5%

    Drug

    Timolol eye drops will be self-admnistered twice daily in the study eye approximately 12 hours apart throughout the study

Treatment groups

42 Participants
are divided into 4 treatment groups
Group A: TimoD implant - Dose 1 (low dose) - Stages 1 and 2Experimental treatment 2 interventions
Group B: TimoD implant - Dose 2 (intermediate dose) - Stages 1 and 2Experimental treatment 2 interventions
Group C: TimoD implant - Dose 3 (high dose) - Stages 1 and 2Experimental treatment 2 interventions
Group D: Timolol eye drops - Stage 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stage 1: Number (%) of participants experiencing adverse events

Time frame
From Screening (up to Day -41) to end of stage 1 (Month 13)
2

Stage 1: Number (%) of participants experiencing adverse events of special interest (AESI)

Time frame
From Screening (up to Day -41) to end of stage 1 (Month 13)
3

Stage 2: Proportion of responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM IOP)

Time frame
Month 3
4

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)

Time frame
Month 3

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EyeD Pharma

Lead sponsor

Source ClinicalTrials.gov
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