Overview
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.
Description
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.
Eligibility
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