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

NCT07036510 | Recruiting Phase 1

• 2 other identifiers: EyeD-010-006U1111-1317-3395
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Ocular hypertension; OHT; Cataract; Timolol; Lens diseases

Outcome Measures

Primary Outcomes (4)

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

  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)

  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)

  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)

  Month 3

Study Arms (4)

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)..

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).

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).

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)

Drug: Timolol eye drops 0.5%

Interventions

TimoD implant DRUG

Consists of 1 TimoD implant administration in the study eye.

Also known as: intraocular implant releasing timolol, investigational drug

TimoD implant - Dose 1 (low dose) - Stages 1 and 2; TimoD implant - Dose 2 (intermediate dose) - Stages 1 and 2; TimoD implant - Dose 3 (high dose) - Stages 1 and 2

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.

Also known as: ACCUJECT™ 2.2.-BL, Investigational device

TimoD implant - Dose 1 (low dose) - Stages 1 and 2; TimoD implant - Dose 2 (intermediate dose) - Stages 1 and 2; TimoD implant - Dose 3 (high dose) - Stages 1 and 2

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

Timolol eye drops - Stage 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• EyeD Pharma: lead

Study Sites (1)

Panama Eye Center

Panama City, Panama

RECRUITING

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Cataract; Lens Diseases

Interventions

Drugs, Investigational

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Central Study Contacts

EyeD Pharma

CONTACT

+3242299000; dpo@eyedpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Stage 1 (Phase 1) will use a sequential assignment design, whereas Stage 2 (Phase 2) will use a parallel assignment design.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

PA (1)