Evaluation of Wear Experience With Daily Contact Lenses

Evaluation of Wear Experience With PRECISION1® Contact Lenses in Biofinity® Contact Lens Wearers

To evaluate the wear experience of current monthly replacement contact lens wearers after they have been fit into a daily disposable contact lens.

Study Overview

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

• 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 to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Currently wear Biofinity® monthly replacement spherical contact lenses.
• 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.

Exclusion Criteria:

• No current ocular inflammation or infection.
• Not currently pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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 participants are fit with the study daily disposable lenses; All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses.	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 Assessment of Precision1® Daily Disposable Contact Lens	Contact Lens Dry Eye Questionnaire (CLDEQ) survey (0-37, with higher scores related to higher symptoms)	2 weeks

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021H0118

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