GlaucomaPhase 1/2NCT07036510
Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery
A Phase 1/2 study testing TimoD implant, Injector system and Timolol eye drops 0.5% in people with Glaucoma and Ocular Hypertension, run by EyeD Pharma at 1 site in Panama.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- TimoD implant, Injector system and Timolol eye drops 0.5%
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePanama
- Study dates
- 12 Jun 2025to Jan 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Feasibility Study to Evaluate the Safety and Efficacy of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery
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.
Read the detailed description
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.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- TimoD implant, Injector system, Timolol eye drops 0.5%
- Keywords
- Glaucoma, Ocular hypertension, OHT, Cataract, Timolol, Lens diseases
- Medical subject headings
- Glaucoma, Ocular Hypertension, Cataract, Lens Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimoD implantDrug
Also called intraocular implant releasing timolol, investigational drug
Consists of 1 TimoD implant administration in the study eye.
Injector systemDevice
Also called ACCUJECT™ 2.2.-BL, Investigational 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
| Study group | Role | What they receive |
|---|---|---|
| TimoD implant - Dose 1 (low dose) - Stages 1 and 2 | Experimental | 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).. Receives: Drug: TimoD implant; Device: Injector system |
| TimoD implant - Dose 2 (intermediate dose) - Stages 1 and 2 | Experimental | 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). Receives: Drug: TimoD implant; Device: Injector system |
| TimoD implant - Dose 3 (high dose) - Stages 1 and 2 | Experimental | 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). Receives: Drug: TimoD implant; Device: Injector system |
| Timolol eye drops - Stage 2 | Active comparator | In Stage 2, participants will be randomly assigned to 1 of 4 treatment groups (3 TimoD dose levels or active comparator) Receives: Drug: Timolol eye drops 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Number (%) of participants experiencing adverse events
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start12 Jun 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Stage 1 (Phase 1) will use a sequential assignment design, whereas Stage 2 (Phase 2) will use a parallel assignment design.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EyeD Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036510
- Sponsor's protocol ID
- EyeD-010-006
- Other IDs
- U1111-1317-3395
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No