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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1317-3395 | Other Identifier | WHO |
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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:
Timolol will be delivered through an investigational drug called 'TimoD implant'.
This implant is placed inside one eye, the study eye, with the help of an instrument (investigational device) called an injector system. This procedure will be performed in conjunction with the cataract surgery.
Three dose ranges of TimoD implant will be tested (low, intermediate, and high) in 3 groups of 6 participants.Participants will receive only one dose. The Timolol will be released slowly through the implant for up to 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TimoD implant | Drug | Consists of 1 TimoD implant administration in the study eye. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| EyeD Pharma | Contact | +3242299000 | dpo@eyedpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panama Eye Center | Recruiting | Panama City | Panama |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D002386 | Cataract |
| D007905 | Lens Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D015507 | Drugs, Investigational |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| 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. |
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