Evaluation of Wear Experience With a Daily Disposable Contact Lens

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

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.

Study Overview

• Status: Completed
• Conditions: Contact Lens
• Intervention / Treatment: Device: Daily Disposable Contact Lens

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All study participants; All subjects are fit into daily disposable contact lenses after wearing their optimized habitual contact lenses for ~ 1 week. Subjects are requested to wear the lenses for two weeks, for a minimum of at least 6 hours per day for 10 days.	Device: Daily Disposable Contact Lens; Soft, daily disposable spherical contact lens used to correct distance vision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Soft Contact Lens; Daily Disposable Contact Lens; Spherical Contact Lens
• Other Study ID Numbers: 2020H0019

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.: Yes