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 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT01015768
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age.
* Understand your rights as a research subject and give written informed consent by signing the Informed Consent Form, Subject Bill of Rights, and Patient Authorization for Use and Release of Health and Research Study Information (HIPAA form).
* Be likely to finish the entire study, understand the study instructions, and be willing to follow the instructions.
* Contact lens prescription between +4.00 D to -9.00 D (spherical equivalent).
* Best correctable visual acuity of at least 20/40 in each eye.
* Willing to de-adapt (do not wear) from habitual contact lenses for a period of at least two days prior to eligibility visit and at least two days prior to the testing day.
* Possess a functional spectacle (eyeglass) prescription to allow adequate vision during the de-adaptation and barrier function determination periods.
* No known allergies, which may interfere with contact lens wear.
* No known systemic (pertaining to general health) disease, or need for medication that may interfere with contact lens wear (i.e. antihistamines, beta-blockers, steroids).
Exclusion Criteria:
* Less than one month successful, full time (defined as at least 8 hours per day, and more than 5 days per week) soft lens wear.
* Clinically significant corneal swelling (greater than grade 3 or 4 on a 0-4 scale), corneal blood vessel growth (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
* Any active ocular infection.
* Prior corneal refractive surgery (i.e., LASIK, PRK, etc).
* Have used medications within 24 hours of study entry or have an ongoing need to use ocular medication.
* Are taking part in any other study or have taken part in a study within the last 14 days
* Have a medical condition that your study eye doctor thinks may make it not appropriate for you to participate in this study.
* Are pregnant, or anticipate becoming pregnant during the course of this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01015768
Study Brief:
Protocol Section:
NCT01015768