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

NCT06382064 | Completed Results FDA Device

• 1 other identifier: 2024H0089
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (1)

• Subjective Assessment of Lens Wear Experience

  Subjective assessment of lens wear experience using a CLDEQ-8 survey (contact lens dry eye questionnaire). There are 8 questions about about the presence and intensity of symptoms when wearing contact lenses. When totaling the scores for each question, the lowest possible score=1 and the highest possible score=37. Higher scores result from more prevalent and intense symptoms.

  After 2 weeks of wear in the 1-week replacement reusable lenses.

Study Arms (1)

Contact Lens Wear Experience

EXPERIMENTAL

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.

Device: Biweekly replacement contact lenses; Device: One week replacement contact lenses

Interventions

Biweekly replacement contact lenses DEVICE

Biweekly replacement reusable contact lenses.

Contact Lens Wear Experience

One week replacement contact lenses DEVICE

One week replacement reusable contact lenses.

Contact Lens Wear Experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Ability to give informed consent
• Current Acuvue® Oasys® spherical lens wearer.
• Distance visual acuity of 20/25 or better with current contact lenses in each eye.
• 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.
• Willing to spend time for the study, which includes: attend three study visits and wear contact lenses on days between study visits.

You may not qualify if:

• Current or active ocular inflammation or infection as determined by the Investigator.
• Currently pregnant or lactating. (Participants will be asked to self-report these conditions).
• Systemic inflammatory disease (i.e. Diabetes, etc.) that could confound study results in the opinion of the investigator.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Dr. Jennifer Fogt
• Organization: The Ohio State University College of Optometry

fogt.78@osu.edu

614-292-0882

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Principal Investigator

Model Details: Subjects will be fit into Acuvue Oasys contact lenses at the first visit to wear for 2 weeks. Subjects will then be fit into PRECISION7 lenses at the second visit to wear for 2 weeks.

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: April 16, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: October 20, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)