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

Not Applicable

Recruiting

• Conditions: Astigmatism Bilateral

• Registration Number: NCT06751225
• Lead Sponsor: Ohio State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-27
• Study Start: 2025-01-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion 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

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Subjective assessment of lens wear experience	3 weeks	VAS assessment of overall vision throughout the day. (0-100 scale; 0=unacceptable 100=excellent)

Trial Locations

Locations (1)

The Ohio State University College of Optometry; 🇺🇸 Columbus, Ohio, United States