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Two Daily Disposable Contact Lenses in Symptomatic Patients

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ClinicalTrials.gov Identifier: NCT03628599
Recruitment Status : Completed
First Posted : August 14, 2018
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.

Condition or disease Intervention/treatment Phase
Myopia Device: Delefilcon A contact lenses Device: Senofilcon A contact lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two Daily Disposable Contact Lenses in Symptomatic Patients
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : September 25, 2018
Actual Study Completion Date : September 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: TOTAL1
Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality
Device: Delefilcon A contact lenses
Water Gradient silicon hydrogel daily disposable contact lenses
Other Name: DAILIES TOTAL1® (DT1)

Active Comparator: 1-DAY
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
Device: Senofilcon A contact lenses
Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology
Other Name: ACUVUE OASYS® 1-DAY




Primary Outcome Measures :
  1. Monocular Corrected Distance Visual Acuity (VA) [ Time Frame: Week 4 ]
    Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.



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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 IRB-approved informed consent form;
  • Soft contact lens wearers in both eyes during the past 3 months;
  • Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
  • Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
  • Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria:

  • Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
  • Intolerance, hypersensitivity, or allergy to any component of the study products;
  • 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).

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): NCT03628599


Locations
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United States, Illinois
Alcon Investigative Site
Bloomington, Illinois, United States, 61701
United States, Kansas
Alcon Investigative Site
Pittsburg, Kansas, United States, 66762
United States, Ohio
Alcon Investigative Site
Powell, Ohio, United States, 43065
United States, Rhode Island
Alcon Investigative Site
Warwick, Rhode Island, United States, 02888
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 20, 2018
Statistical Analysis Plan  [PDF] August 13, 2018


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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03628599     History of Changes
Other Study ID Numbers: CLS312-P001
First Posted: August 14, 2018    Key Record Dates
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019
Last Verified: June 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:
Symptomatic
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases