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Clinical Validation of DACP Digital Design

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: NCT03567005
Recruitment Status : Completed
First Posted : June 25, 2018
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.

Condition or disease Intervention/treatment Phase
Refractive Errors Device: Nelfilcon A digital contact lenses Device: Nelfilcon A contact lenses Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Validation of DACP Digital Design
Actual Study Start Date : June 25, 2018
Actual Primary Completion Date : August 26, 2018
Actual Study Completion Date : August 26, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
DACP Digital then DACP
Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.
 Device: Nelfilcon A digital contact lenses
Silicone hydrogel digital contact lenses
Other Names:
  • DAILIES® AquaComfort Plus® Digital
  • DACP Digital

Device: Nelfilcon A contact lenses
Silicone hydrogel spherical contact lenses
Other Names:
  • DAILIES® AquaComfort Plus®
  • DACP
DACP then DACP Digital
Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.
 Device: Nelfilcon A digital contact lenses
Silicone hydrogel digital contact lenses
Other Names:
  • DAILIES® AquaComfort Plus® Digital
  • DACP Digital

Device: Nelfilcon A contact lenses
Silicone hydrogel spherical contact lenses
Other Names:
  • DAILIES® AquaComfort Plus®
  • DACP


Outcome Measures
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Primary Outcome Measures :
  1. Distance Visual Acuity (VA) (logMAR, OU) [ Time Frame: Day 7, each product ]
    VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.


Secondary Outcome Measures :
  1. Overall Vision [ Time Frame: Day 7, each product ]
    Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to sign an IRB/IEC approved Informed Consent form;
  • Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
  • Experiencing symptoms of eye strain from using technology;
  • Willing to wear study lenses each day;
  • Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
  • Willing to NOT use rewetting/lubricating drops at any time during the study;
  • Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
  • Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.

Exclusion Criteria:

  • Conditions, use of medications, injury, or surgery, as specified in the protocol;
  • 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);
  • Pregnant.
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): NCT03567005


Locations
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United States, Illinois
Alcon Investigative Site
Bloomington, Illinois, United States, 61701
United States, Ohio
Alcon Investigative Site
Powell, Ohio, United States, 43065
United States, Tennessee
Alcon Investigative Site
Brentwood, Tennessee, United States, 37027
Alcon Investigative Site
Memphis, Tennessee, United States, 38104
Alcon Investigative Site
Memphis, Tennessee, United States, 38111
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon Research Alcon Research
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] July 16, 2018
Statistical Analysis Plan  [PDF] July 26, 2018

More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03567005    
Other Study ID Numbers: CLD523-C001
First Posted: June 25, 2018    Key Record Dates
Results First Posted: June 18, 2019
Last Update Posted: June 18, 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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases