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Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2

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ClinicalTrials.gov Identifier: NCT03888482
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.

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

Detailed Description:
Subjects will be expected to attend 3 study visits and wear study lenses for approximately 14 - 20 days (7 - 10 days for each product).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2
Actual Study Start Date : April 26, 2019
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
DDT2, then Clariti
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
Device: Verofilcon A contact lenses
Investigational daily disposable soft contact lenses
Other Name: DDT2

Device: Somofilcon A contact lenses
Commercially available daily disposable soft contact lenses
Other Names:
  • clariti® 1 day
  • Clariti

Clariti, then DDT2
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
Device: Verofilcon A contact lenses
Investigational daily disposable soft contact lenses
Other Name: DDT2

Device: Somofilcon A contact lenses
Commercially available daily disposable soft contact lenses
Other Names:
  • clariti® 1 day
  • Clariti




Primary Outcome Measures :
  1. Visual acuity at distance [ Time Frame: Day 8, each product ]
    Visual acuity will be recorded in logarithm minimum angle of resolution (logMAR) for each eye individually



Information from the National Library of Medicine

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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 Informed Consent Form that has been approved by an Institutional Review Board.
  • Willing and able to attend all scheduled study visits as required per protocol.
  • Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
  • Manifest cylinder of ≤ 0.75 diopter (D) in each eye.
  • Best corrected visual acuity (VA) of 20/25 or better in each eye.
  • Able to wear contact lenses within a range of sphere power from -1.00 to -6.00 D (0.25 D steps) and VA of 20/25 or better in each eye with fitting set lenses.

Exclusion Criteria:

  • Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear.
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
  • History of ocular or intraocular surgery, including refractive surgery and/or irregular cornea.
  • Biomicroscopy findings at baseline that are moderate (grade 3) or higher and/or corneal vascularization that is mild (grade-2) or higher.
  • Current or history of pathologically dry eye in either eye that would preclude contact lens wear.
  • Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.
  • 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.
  • Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear.
  • Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.

Other protocol-specified 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): NCT03888482


Locations
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United States, Florida
Alcon Investigative Site
Jacksonville, Florida, United States, 32256
Alcon Investigative Site
Maitland, Florida, United States, 32751
Alcon Investigative Site
Orlando, Florida, United States, 32803
United States, Illinois
Alcon Investigative Site
Bloomington, Illinois, United States, 61701
United States, Ohio
Alcon Investigative Site
Powell, Ohio, United States, 43065
United States, Rhode Island
Alcon Investigative Site
Warwick, Rhode Island, United States, 02888
United States, Tennessee
Alcon Investigative Site
Brentwood, Tennessee, United States, 37027
Alcon Investigative Site
Memphis, Tennessee, United States, 38111
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Study Director Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03888482     History of Changes
Other Study ID Numbers: CLE383-C010
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 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
Keywords provided by Alcon Research:
Visual acuity
VA
Daily disposable contact lenses
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases