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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT04024293
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent
* A clinical diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma (NTG), for OAG patients
* A clinical diagnosis of OHT, for OHT patients
* For all patients:
Open angles on gonioscopy Aged ≥ 18 years, either gender Both central corneal radii (CCR) between 7.3mm (46.23D) and 8.05mm (41.93D), with a maximum difference of 2D between the 2 radii in the study eye Central corneal thickness (CCT) between 490µm and 600µm in the study eye
Exclusion Criteria:
* Ocular pathology (other than glaucoma or OHT)
* Previous glaucoma, cataract or refractive laser/surgery
* Corneal or conjunctival abnormality, precluding contact lens adaptation
* Insufficiency of lacrimal secretion
* Subjects with allergy to corneal anesthetic
* Subjects with contraindications for silicone contact lens wear
* Subjects with contraindications for Diamox or Latanoprost or Timolol
* Skin irritations, skin eczema or other indications against the wearing of adhesive patches
* Subjects unable or unwilling to comply with the study procedures
* Subjects lacking the capacity to consent (vulnerable persons)
* Subjects with history of cardiac failure, treated cardiopathy or renal failure
* Subjects with known cognitive disorders
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04024293
Study Brief:
Protocol Section:
NCT04024293