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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06382064
Other study ID # 2024H0089
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 16, 2024
Est. completion date May 2025

Study information

Verified date April 2024
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date May 2025
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Biweekly replacement contact lenses
Biweekly replacement reusable contact lenses.
One week replacement contact lenses
One week replacement reusable contact lenses.

Locations

Country Name City State
United States The Ohio State University College of Optometry Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective assessment of lens wear experience Subjective assessment of lens wear experience using a CLDEQ-8 survey After 2 weeks of wear in the 1-week replacement reusable lenses.
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