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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT03605303
Eligibility Criteria:
Inclusion Criteria:
-Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).
5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
6. The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.
7. The subject's refractive cylinder must be \< 0.75 D in each eye.
8. The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria:
1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
4. Any ocular infection.
5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
6. Monovision or multi-focal contact lens correction.
7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
10. Suspicion of or recent history of alcohol or substance abuse.
11. History of serious mental illness.
12. History of seizures.
13. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03605303
Study Brief:
Protocol Section:
NCT03605303