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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT06955403
Eligibility Criteria:
• Inclusion Criteria: Adults, 18- to 40-year-old, AOA CL wearers with best-corrected 20/20 visual acuity or better.
* Participants will be required to have worn AOA CLs for at least 3 months in the past year and currently wearing these CLs.
* All participants will be required to have a CLDEQ-8 score \<12 while wearing their habitual CLs (AOA CLs) and to indicate that they are satisfied with AOA CLs (Yes/No).
* Participants will be required to be able to wear P7A CLs (astigmatism ≥0.75D OD/OS).
* Astigmatism ranging from 0.75 D to 2.50 D in each eye
* Participants will be required to wear the study CLs for ≥13 hours with no overnight wear
* Participants will be willing to wear the CL every day of the week, except during the washout period
* Participants will be required to provide a glasses prescription that is less than 3 years old
* \-
* Exclusion Criteria:
* \- Have presbyopia and/or need a reading add as determined during their initial manifest refraction
* Have worn P7A in the past
* Are past rigid CL wearers
* Have a history of being diagnosed with dry eye or ocular allergies
* Have known systemic health conditions that are thought to alter tear film physiology
* Have a history of viral eye disease
* Have a history of ocular surgery
* Have a history of severe ocular trauma
* Have a history of corneal dystrophies or degenerations
* Have active ocular infection or inflammation
* Are currently using isotretinoin-derivatives or ocular medications
* Are pregnant or breast feeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06955403
Study Brief:
Protocol Section:
NCT06955403