Recruiting

New Timolol Sustained-Release Intraocular Implant for Open-Angle Glaucoma or Ocular Hypertension During Cataract Surgery

Study Aim

This early-stage study examines a new Timolol sustained-release implant for open-angle glaucoma or ocular hypertension during cataract surgery, focusing on its safety and potential side effects.

What is being tested

TimoD implant

+ Injector system

DrugDevice

Who is being recruted

Cataract+2

+ Eye Diseases

+ Glaucoma

Over 40 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Phase 1

Interventional

Study Start: June 2025

See protocol details

Summary

Principal SponsorEyeD Pharma

Study ContactEyeD Pharma

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 12, 2025

Actual date on which the first participant was enrolled.

This study aims to test the safety of a new treatment method for people with open-angle glaucoma or ocular hypertension who are undergoing cataract surgery. The treatment involves a special Timolol implant called "TimoD" that is designed to release medication slowly over time. The study is important because it could lead to a more effective way of managing eye pressure in patients with these conditions, potentially improving long-term eye health and preventing further vision loss. Participants in the study will have the Timolol implant placed inside one of their eyes during their cataract surgery using a specific injector device. The study will test three different doses of the implant, categorized as low, intermediate, and high, with each group consisting of six participants receiving only one dose. The implant will release Timolol gradually for up to one year. The study will monitor the safety of this method to determine how well it works in managing eye pressure and any associated risks.

Official TitleEarly Feasibility, Open-Label, Dose-Escalating, Non-Randomized Study to Evaluate the Safety of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery

NCT07036510

Principal SponsorEyeD Pharma

Study ContactEyeD Pharma

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CataractEye DiseasesGlaucomaLens DiseasesOcular Hypertension

Criteria

4 inclusion criteria required to participate

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

4 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants in Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.

Group II

Experimental

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.

Group III

Experimental

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Panama Eye Center

Panama City, PanamaOpen Panama Eye Center in Google Maps

Recruiting

One Study Center