Wear Experience With Daily Contact Lenses Over a Long Day

Evaluation of Wear Experience With PRECISION1® Contact Lenses on Long Lens-wear Days

This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.

Study Overview

• Status: Completed
• Conditions: Contact Lens
• Intervention / Treatment: Device: Precision1® Daily Disposable Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 35
• 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 to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be a current spherical contact lens wearer with longs days of lens wear.
• 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).
• Recent eye exam within the past year.
• Must have a working smart phone and be willing to download an app and/or receive and respond to texts.
• Ability to give informed consent.
• Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3.

Exclusion Criteria:

• No current ocular inflammation or infection as assessed by the study investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Daily Disposable Contact Lens; All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks.	Device: Precision1® Daily Disposable Contact Lens; Soft, spherical contact lens used to correct distance vision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS)	Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent.	Up to 14 days

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2020
• Primary Completion (ACTUAL): December 8, 2020
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (ACTUAL): September 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Soft Contact Lens; Daily Disposable Contact Lens; Spherical Contact Lens
• Other Study ID Numbers: 2020H0324

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