RECRUITING

Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism

Quick Facts

Study Start:2025-01-10

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06751225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses) 2. Subjects must have 20/20 or better best corrected visual acuity. 3. 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) 4. Ability to give informed consent 5. 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. 6. 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. 7. Currently not using eye lubricating drops and willing to not use during study. 8. Either gender and 18-40 years of age. 9. Any racial or ethnic origin	1. Any active ocular inflammation or infection. 2. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. 3. Are presbyopic and require or habitually uses reading glasses for near work 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable 5. History of refractive surgery 6. Meets the diagnosis of dry eye disease with OSDI screening score ≥13. 7. Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein 8. Is pregnant or lactating or planning a pregnancy during enrollment in the study 9. Is participating in another clinical research study that includes invasive ocular tests 10. An inability to perform contact lens application and removal after instruction.

Inclusion Criteria

Exclusion Criteria

1. Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses)
2. Subjects must have 20/20 or better best corrected visual acuity.
3. 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)
4. Ability to give informed consent
5. 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.
6. 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.
7. Currently not using eye lubricating drops and willing to not use during study.
8. Either gender and 18-40 years of age.
9. Any racial or ethnic origin

1. Any active ocular inflammation or infection.
2. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
3. Are presbyopic and require or habitually uses reading glasses for near work
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
5. History of refractive surgery
6. Meets the diagnosis of dry eye disease with OSDI screening score ≥13.
7. Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein
8. Is pregnant or lactating or planning a pregnancy during enrollment in the study
9. Is participating in another clinical research study that includes invasive ocular tests
10. An inability to perform contact lens application and removal after instruction.

Contacts and Locations

Study Contact

Emma Grant

CONTACT

614-292-8858

grant.845@osu.edu

Jennifer Fogt

CONTACT

614-292-0882

fogt.78@osu.edu

Study Locations (Sites)

The Ohio State University College of Optometry

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-10

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-01-10

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Astigmatism Bilateral