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:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT03311204
Eligibility Criteria:
Inclusion Criteria:
* Age of 18 years or above
* Understand their rights as a research subject
* Willing and able to sign a statement of informed consent
* Normal ocular status, defined as a minimum of 20/40 visual acuity in each eye; clear corneas without scarring, opacities, or vascularization, as determined by biomicroscopic examination
* Normal external examination
* Normal puncta without punctal plugs
* Ability to cooperate with the required procedures of diagnostic agent installation, eyelid eversion, and examination.
* Contact lens wearers who have worn lenses for at least 6 months, used contact lenses for 3 weeks before the evaluation visit and used these lenses at least four times a week. These contact lens wearers will be on daily wearing modality, where the subject is supposed to wear it for at least for 6 hours, only during the day and remove the lenses during sleep.
Exclusion Criteria:
* Any ocular or systemic disease that might influence the tear film and especially subjects with a history of episodes of epilepsy.
* Subjects with eyelid inflammation of more than grade 2 will be excluded from the study as they need therapeutic intervention.
* All conjunctival abnormalities, including pingueculae greater than 1 mm in diameter, location closer than 2 mm to the limbus, or elevated more than 0.2 mm
* All forms of conjunctivitis, including allergic conjunctivitis
* Fluorescein corneal staining of grade 2 or more, after a single installation of non-preserved fluorescein solution followed by examination 1 minute after installation
* Current ocular infection or treatment of such infections with ocular or systemic medications
* Current use of any prescription or non-prescription ocular or systemic medications, including antihistamines
* Use of artificial tear preparations during the period 2 hours before the examination
* Use of any ocular ointment during the 3 days before the examination
* Any history of ocular surgery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03311204
Study Brief:
Protocol Section:
NCT03311204