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Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

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ClinicalTrials.gov Identifier: NCT03349632
Recruitment Status : Completed
First Posted : November 21, 2017
Results First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Condition or disease Intervention/treatment Phase
Refractive Error Device: verofilcon A contact lenses Device: senofilcon A contact lenses Device: stenfilcon A contact lenses Device: etafilcon A contact lenses Not Applicable

Detailed Description:
The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Actual Study Start Date : January 10, 2018
Actual Primary Completion Date : February 16, 2018
Actual Study Completion Date : February 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
DD T2/Oasys 1-Day
Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized
Device: verofilcon A contact lenses
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Other Name: DDT2

Device: senofilcon A contact lenses
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • ACUVUE OASYS® 1-Day with HydraLuxe™ Technology
  • Oasys 1-Day

DD T2/MyDay
Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
Device: verofilcon A contact lenses
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Other Name: DDT2

Device: stenfilcon A contact lenses
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • MyDay®
  • MyDay

DD T2/Moist
Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
Device: verofilcon A contact lenses
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Other Name: DDT2

Device: etafilcon A contact lenses
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • 1-Day ACUVUE® MOIST
  • Moist




Primary Outcome Measures :
  1. Overall Quality of Vision [ Time Frame: Day 8, each product ]
    Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.



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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

Inclusion Criteria:

  • Able to understand and must sign an approved Informed Consent Form
  • Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
  • Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
  • Willing to stop wearing habitual contact lenses for the duration of study participation
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
  • Routinely sleeps in habitual contact lenses
  • Currently wears Oasys 1-Day, MyDay, or Moist contact lenses
  • Other protocol-defined exclusion criteria may apply

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): NCT03349632


Locations
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United States, Florida
Alcon Investigative Site
Maitland, Florida, United States, 32751
Alcon Investigative Site
Pensacola, Florida, United States, 32503
United States, Georgia
Alcon Investigative Site
Johns Creek, Georgia, United States, 30097
Sponsors and Collaborators
Alcon Research
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] November 2, 2017
Statistical Analysis Plan  [PDF] November 17, 2017


Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03349632     History of Changes
Other Study ID Numbers: CLE383-C004
First Posted: November 21, 2017    Key Record Dates
Results First Posted: February 22, 2019
Last Update Posted: February 22, 2019
Last Verified: January 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alcon Research:
Contact lenses
Myopia
Near-sighted
Daily disposable
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases