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Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1

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: NCT04527978
Recruitment Status : Completed
First Posted : August 27, 2020
Results First Posted : November 23, 2021
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.

Condition or disease Intervention/treatment Phase
Refractive Errors Myopia Device: Verofilcon A contact lenses Device: Nesofilcon A contact lenses Not Applicable

Detailed Description:
Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
Actual Study Start Date : September 15, 2020
Actual Primary Completion Date : November 6, 2020
Actual Study Completion Date : November 6, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
PRECISION1, then Biotrue ONEday
Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
 Device: Verofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
Other Name: PRECISION1™

Device: Nesofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
Other Names:
  • Biotrue ONEday
  • Bausch + Lomb Biotrue® ONEday
Biotrue ONEday, then PRECISION1
Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
 Device: Verofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
Other Name: PRECISION1™

Device: Nesofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
Other Names:
  • Biotrue ONEday
  • Bausch + Lomb Biotrue® ONEday


Outcome Measures
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Primary Outcome Measures :
  1. Distance Visual Acuity (VA) With Study Lenses [ Time Frame: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type ]
    Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any ocular condition that contraindicates contact lens wear.
  • Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
  • Other protocol-specified exclusion criteria may apply.
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): NCT04527978


Locations
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United States, Florida
Alcon Investigator 6565
Maitland, Florida, United States, 32751
United States, Minnesota
Alcon Investigator 6402
Medina, Minnesota, United States, 55340
United States, Ohio
Alcon Investigator 6313
Powell, Ohio, United States, 43065
United States, Texas
Alcon Investigator 8028
Wichita Falls, Texas, United States, 76308
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: CDMA Project Lead, Vision Care Alcon Research, LLC
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] August 13, 2020
Statistical Analysis Plan  [PDF] September 11, 2020

More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT04527978    
Other Study ID Numbers: CLE383-P003
First Posted: August 27, 2020    Key Record Dates
Results First Posted: November 23, 2021
Last Update Posted: November 23, 2021
Last Verified: October 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.: No
Keywords provided by Alcon Research:
Daily disposable contact lenses
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases