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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT01495312
Eligibility Criteria:
Inclusion Criteria:
* Subjects must correspond to all other inclusion criteria in order to be eligible for the investigation.
* Subject is able to comply with the study procedures
* 18-80 years old
* Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of \> 22 mmHg at the screening visit and under ocular hypotensive treatment.
* Subject has consented to be in the trial
* Visual acuity of 20/200 or better
* Ability to understand the character and individual consequences of the study
* For women of childbearing potential, adequate contraception
Exclusion Criteria:
* Subjects presenting with any of the following criteria will not be included in the trial:
* Subjects with contraindications for wearing contact lenses
* Severe dry eye syndrome
* Keratoconus or other corneal abnormality
* Conjunctival or intraocular inflammation
* Eye surgery prior to and throughout the study.
* Full frame metal glasses during SENSIMED Triggerfish® monitoring
* Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
* Pregnancy and lactation
* Simultaneous participation in other clinical studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01495312
Study Brief:
Protocol Section:
NCT01495312