NCT07036510

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 main questions it aims to answer are how safe are three different doses of the investigational drug is and how the body tolerates it. The study will also check:

  • how safely the implant is placed in and removed from the eye and how the body responds to the procedure,
  • if and the amount of Timolol released in the bloodstream,
  • if there is any positive effect on the pressure inside the eye.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jun 2025Jan 2027

Study Start

First participant enrolled

June 12, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

June 17, 2025

Last Update Submit

June 17, 2025

Conditions

GlaucomaOcular Hypertension

Keywords

GlaucomaOcular hypertensionOHTCataractTimololLens diseases

Outcome Measures

Primary Outcomes (2)

  • Number (%) of participants experiencing adverse events

    From Screening (up to Day -41) to end of study (Month 13)

  • Number (%) of participants experiencing adverse events of special interest (AESI)

    From Screening (up to Day -41) to end of study (Month 13)

Study Arms (3)

TimoD implant - Dose 1 (low dose)

EXPERIMENTAL

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

Drug: TimoD implantDevice: Injector system

TimoD implant - Dose 2 (intermediate dose)

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.

Drug: TimoD implantDevice: Injector system

TimoD implant - Dose 3 (high dose)

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.

Drug: TimoD implantDevice: Injector system

Interventions

TimoD implantDRUG

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)TimoD implant - Dose 2 (intermediate dose)TimoD implant - Dose 3 (high dose)
Injector systemDEVICE

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)TimoD implant - Dose 2 (intermediate dose)TimoD implant - Dose 3 (high dose)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Panama Eye Center

Panama City, Panama

RECRUITING

MeSH Terms

Conditions

GlaucomaOcular HypertensionCataractLens Diseases

Interventions

Drugs, Investigational

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Central Study Contacts

EyeD Pharma

CONTACT

+3242299000dpo@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

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

June 25, 2025

Record last verified: 2025-06

Locations

PA(1)