Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery
Recruiting · NCT07036510 · Interventional (participants receive a specific treatment) · Lead sponsor: EyeD Pharma
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Panama Eye Center - Panama City, Panama