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

October 15, 2025 updated by: Jennifer Fogt, Ohio State University

Evaluation of Wear Experience With PRECISION7® Contact Lenses in Habitual Acuvue® Oasys® Lens Wearers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Biweekly replacement contact lenses
Biweekly replacement reusable contact lenses.
Device: One week replacement contact lenses
One week replacement reusable contact lenses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Assessment of Lens Wear Experience
Time Frame: After 2 weeks of wear in the 1-week replacement reusable lenses.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Actual)

December 9, 2024

Study Completion (Actual)

December 9, 2024

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Estimated)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 15, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024H0089

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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