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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism Bilateral
• Intervention / Treatment: Device: One week replacement soft contact lenses

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contact Lens Wear Experience; One week replacement soft contact lenses will be worn for 3 weeks.	Device: One week replacement soft contact lenses; One week replacement soft contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Assessment of Lens Wear Experience	VAS assessment of overall vision. (0-100 scale; 0=unacceptable 100=excellent)	After 3 weeks of lens wear

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Actual): November 4, 2025
• Study Completion (Actual): November 4, 2025

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 2024H0379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No