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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06382064
• Other study ID #: 2024H0089
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Myopia

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.