Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT07007260
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years or older;
* Confirmed diagnosis of Primary Open angle Glaucoma (POAG) - following a complete ophthalmological examination (ocular tonometry, slit lamp ocular examination, visual field and Optical coherence tomography); Subject has provided signed and dated written informed consent before admission to the study.
* Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
* Participants need to have visual acuity of Snellen ≥ 6/12 (0.5) or better.
* Have performed at least two reliable VFs (SITA-Fast 24-2), with \<33% fixation losses and \<15% false positives
* Those taking NAM already will undergo a 1-month washout period before commencing the study.
Exclusion Criteria:
* Participants must not be pregnant or breastfeeding women;
* Investigator considers the subject unfit for the study as a result of medical history, physical examination, or screening tests;
•● VF damage worse than -10dB in the best eye and -16dB in the worse eye or a paracentral spot with -10dB or less in any eye),
* OP \>35mmHg in any eye or a mean IOP of 30mmHg or higher (two measurements), •inability to perform VFs,
* those unwilling to abstain from NAM supplements,
* allergic to NAM/niacin,
* diagnosed with cancer in the last 5 years (except treated basal or squamous cell carcinoma),
* a history of liver disease or stomach ulcers,
* disease that prevents long-term follow-up, neurologic or other non-glaucomatous conditions apart from cataract that may affect the VF
* Patient is diagnosed with primary angle closure glaucoma;
* Patient is diagnosed with secondary glaucoma (e.g. posttraumatic, post inflammatory, steroid induced, pseudo exfoliative, pigmentary, etc.);
* Patient is diagnosed with very advanced glaucoma (foveal fixation threatened or absent and, thus, unreliable perimetry);
* Participants who are currently on NAM will be asked to stop taking the tablets for a month prior to screening visit.
* Patient is diagnosed with other significant ocular pathologies (advanced cataract, pathologic myopia, corneal ectasias or dystrophies, sever amblyopia, vitreoretinal disease, active ocular inflammation, significant sequelae of ocular inflammation);
* Unreliable ophthalmological investigations and non-compliance with examinations (e.g. high percentage of false negative and false positive errors when examining the visual field).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07007260
Study Brief:
Protocol Section:
NCT07007260