Safety of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40+
SponsorEyeD Pharma
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- TimoD implant
- Injector system
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov