Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers

NCT ID: NCT06382064

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2024-12-09

Brief Summary

This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contact Lens Wear Experience

Participants will be enrolled in the study for 4 weeks. Biweekly replacement contact lenses will be worn for the first 2 weeks. One-week replacement lenses worn for second 2 weeks.

Group Type: EXPERIMENTAL

Biweekly replacement contact lenses

Intervention Type: DEVICE

Biweekly replacement reusable contact lenses.

One week replacement contact lenses

Intervention Type: DEVICE

One week replacement reusable contact lenses.

Interventions

Biweekly replacement contact lenses

Biweekly replacement reusable contact lenses.

Intervention Type: DEVICE

One week replacement contact lenses

One week replacement reusable contact lenses.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. At least 18 years of age

2. Ability to give informed consent

3. Current Acuvue® Oasys® spherical lens wearer.

4. Distance visual acuity of 20/25 or better with current contact lenses in each eye.

5. Good general health defined by, medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.

6. Willing to spend time for the study, which includes: attend three study visits and wear contact lenses on days between study visits.

Exclusion Criteria

1. Current or active ocular inflammation or infection as determined by the Investigator.

2. Currently pregnant or lactating. (Participants will be asked to self-report these conditions).

3. Systemic inflammatory disease (i.e. Diabetes, etc.) that could confound study results in the opinion of the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Fogt

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University College of Optometry

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2024H0089

Identifier Type: -

Identifier Source: org_study_id