A Phase 1/2 interventional study of TimoD implant and Injector system in Glaucoma and Ocular Hypertension, sponsored by EyeD Pharma. Recruiting at 1 site in Panama. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by EyeD Pharma · Phase 1/2, Interventional, and Other
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.
Timolol will be administered using an investigational drug product called the TimoD implant.
The implant will be placed in one eye (the study eye) using an instrument called an injector system (an investigational device). The implant procedure will be performed during cataract surgery.
Stage 1: Three dose levels of the TimoD implant (low, intermediate, and high) will be evaluated in three groups of six participants each. Participants will be assigned sequentially to a treatment group and will receive a single implant containing one of the three dose levels. Participants in Stage 1 will be followed for 1 year.
Stage 2: The same three dose levels of the TimoD implant will be evaluated further. In addition, a fourth treatment group receiving an approved control treatment (timolol eye drops) will be included. Six participants will be randomized to each treatment group. Participants in Stage 2 will be followed for 3 years.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 42 is below the median of 61 across 964 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →EyeD Pharma is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In Stage 1, participants in Group 1 will be enrolled first and will receive a low-dose TimoD implant in the study eye on Day 1. In Stage 2, participants will be randomly assigned to 1 of 4 treatment groups (3 TimoD dose levels or active comparator)..
Drug: TimoD implant · Device: Injector system
In Stage 1, participants in Group 2 will receive an intermediate dose of TimoD implant in the study eye on Day 1 if all participants in Group 1 have completed a 4-week treatment period with the lowest dose of TimoD implant and providing there are no safety issues in Group 1. In Stage 2, participants will be randomly assigned to 1 of 4 treatment groups (3 TimoD dose levels or active comparator).
Drug: TimoD implant · Device: Injector system
In Stage 1, participants in Group 3 will receive a high dose of TimoD implant in the study eye on Day 1 if all participants in Group 2 have completed a 4-week treatment period with the intermediate dose, providing there are no safety issues in Group 2. In Stage 2, participants will be randomly assigned to 1 of 4 treatment groups (3 TimoD dose levels or active comparator).
Drug: TimoD implant · Device: Injector system
In Stage 2, participants will be randomly assigned to 1 of 4 treatment groups (3 TimoD dose levels or active comparator)
Drug: Timolol eye drops 0.5%
Consists of 1 TimoD implant administration in the study eye.
Also known as: intraocular implant releasing timolol, investigational drug
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.
Also known as: ACCUJECT™ 2.2.-BL, Investigational device
Timolol eye drops will be self-admnistered twice daily in the study eye approximately 12 hours apart throughout the study
Stage 1: Number (%) of participants experiencing adverse events
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Month 3
Started Jun 2025 (actual). Primary completion is estimated for Jan 2027, 19 months after the start.
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Studies of the drug tested here: Drugs, Investigational
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