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Wear Experience With Daily Contact Lenses Over a Long Day

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04535310
Recruitment Status : Completed
First Posted : September 1, 2020
Last Update Posted : April 13, 2021
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Jennifer Fogt, Ohio State University

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

Condition or disease Intervention/treatment Phase
Contact Lens Device: Precision1® Daily Disposable Contact Lens Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Wear Experience With PRECISION1® Contact Lenses on Long Lens-wear Days
Actual Study Start Date : October 13, 2020
Actual Primary Completion Date : December 8, 2020
Actual Study Completion Date : March 31, 2021
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Subjective comfort and vision as assessed using the Visual Analog Scale (VAS) [ Time Frame: Up to 14 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535310


Locations
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United States, Ohio
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Alcon Research
Investigators
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Principal Investigator: Jennifer Fogt, OD, MS The Ohio State University College of Optometry
More Information
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Responsible Party: Jennifer Fogt, Associate Professor Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT04535310    
Other Study ID Numbers: 2020H0324
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jennifer Fogt, Ohio State University:
Daily Disposable Contact Lens
Spherical Contact Lens
Soft Contact Lens