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Performance Assessment of a Modified Daily Disposable Contact Lens

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: NCT03762668
Recruitment Status : Completed
First Posted : December 4, 2018
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

Condition or disease Intervention/treatment Phase
Refractive Errors Device: Modified Delefilcon A Contact Lenses Device: Delefilcon A Contact Lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Performance Assessment of a Modified Daily Disposable Contact Lens
Actual Study Start Date : December 3, 2018
Actual Primary Completion Date : January 7, 2019
Actual Study Completion Date : January 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MDACL, then DACL
Modified delefilcon A contact lenses worn first, followed by delefilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
Device: Modified Delefilcon A Contact Lenses
Spherical soft daily disposable contact lens
Other Name: MDACL

Device: Delefilcon A Contact Lenses
Spherical soft daily disposable contact lens
Other Name: DACL

DACL, then MDACL
Delefilcon A contact lenses worn first, followed by modified delefilcon A contact lenses, as randomized. Each product will be worn bilaterally for approximately 1 week in a daily disposable modality.
Device: Modified Delefilcon A Contact Lenses
Spherical soft daily disposable contact lens
Other Name: MDACL

Device: Delefilcon A Contact Lenses
Spherical soft daily disposable contact lens
Other Name: DACL




Primary Outcome Measures :
  1. High Contrast Distance Visual Acuity (VA) at Each Visit [ Time Frame: Up to Day 7, each product ]
    VA will be tested at 3 or 6 meters using logMAR (logarithm of the minimum angle of resolution) charts at high contrast. VA is calculated based on the total number of letters read incorrectly, and a lower logMAR value indicates better visual acuity.



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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 sign an approved Informed Consent form;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
  • Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
  • Monocular (only one eye with functional vision);
  • Other protocol-specified 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): NCT03762668


Locations
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United States, Florida
Alcon Investigative Site
Maitland, Florida, United States, 32751
Alcon Investigative Site
Orlando, Florida, United States, 32803
Alcon Investigative Site
West Palm Beach, Florida, United States, 33405
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon, A Novartis Division Alcon, A Novartis Division

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03762668     History of Changes
Other Study ID Numbers: CLP691-C002
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alcon Research:
Contact lens
Vision correction
Visual acuity
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases