RecruitingPhase 1/2

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

Panama42 participantsStarted 2025-06-12

Plain-language 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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: Month 3

Trial details

NCT IDNCT07036510

SponsorEyeD Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

EyeD Pharma

+3242299000 dpo@eyedpharma.com

View on ClinicalTrials.gov More Glaucoma trials

Plain-language summary

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: Month 3