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

NCT06751225 | Recruiting FDA Device

• 1 other identifier: 2024H0379
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism Bilateral

Outcome Measures

Primary Outcomes (1)

• Subjective assessment of lens wear experience

  VAS assessment of overall vision throughout the day. (0-100 scale; 0=unacceptable 100=excellent)

  3 weeks

Study Arms (1)

Contact Lens Wear Experience

EXPERIMENTAL

One week replacement soft contact lenses will be worn for 3 weeks.

Device: One week replacement soft contact lenses

Interventions

One week replacement soft contact lenses DEVICE

One week replacement soft contact lenses

Contact Lens Wear Experience

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: collaborator
• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

RECRUITING

Central Study Contacts

Emma Grant

CONTACT

614-292-8858; grant.845@osu.edu

Jennifer Fogt

CONTACT

614-292-0882; fogt.78@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects will be fit into the one week replacement soft contact lens to wear for 3 weeks.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: January 21, 2025
• Primary Completion: November 1, 2025
• Study Completion: February 28, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)