RecruitingNot ApplicableNCT06751225
Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism
Sponsor
Ohio State University
Enrollment
60 participants
Start Date
Jan 21, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.
Eligibility
Min Age: 18 YearsMax Age: 40 Years
Inclusion Criteria9
- Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses)
- Subjects must have 20/20 or better best corrected visual acuity.
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
- Ability to give informed consent
- Willing to spend time for the study. Subjects will be required to attend three study visits and wear contact lenses on days between study visits.
- Willing and able to wear contact lenses for at least 8 hours per day for 5 days per week during the study as daily wear.
- Currently not using eye lubricating drops and willing to not use during study.
- Either gender and 18-40 years of age.
- Any racial or ethnic origin
Exclusion Criteria10
- Any active ocular inflammation or infection.
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- Are presbyopic and require or habitually uses reading glasses for near work
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
- History of refractive surgery
- Meets the diagnosis of dry eye disease with OSDI screening score ≥13.
- Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein
- Is pregnant or lactating or planning a pregnancy during enrollment in the study
- Is participating in another clinical research study that includes invasive ocular tests
- An inability to perform contact lens application and removal after instruction.
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Interventions
DEVICEOne week replacement soft contact lenses
One week replacement soft contact lenses
Locations(1)
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NCT06751225