Evaluation of Wear Experience With a Daily Disposable Contact Lens

Contact Lens Clinical Trial

Official title:

Evaluation of Wear Experience With PRECISION1® Contact Lenses in Previous Acuvue® Oasys® Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296877
• Other study ID #: 2020H0019
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.

Description:

This is a single arm, non-comparative study. All participants were habitual lens wearers of the same brand of lenses, and were re-fit with the study lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be current Acuvue® Oasys® spherical contact lens wearers.

• Distance visual acuity of 20/25 or better with current contact lenses.

• Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).

• Ability to give informed consent.

• Willing to spend time for the study, which includes attending two study visits and wearing contact lenses on days between study visits.

• Either gender.

• Any racial or ethnic origin.

Exclusion Criteria:

• No current ocular inflammation or infection.

• Not currently pregnant or lactating.

Related Conditions & MeSH terms

• Contact Lens

Intervention

Device:
• Daily Disposable Contact Lens
Soft, daily disposable spherical contact lens used to correct distance vision.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey	Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses.	2 weeks