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Trial record 2 of 24 for:    SELECT-1

Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control 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: NCT03372551
Recruitment Status : Completed
First Posted : December 13, 2017
Results First Posted : May 29, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.

Condition or disease Intervention/treatment Phase
Myopia Device: somofilcon A 1 day test lens Device: somofilcon A 1 day control lens Not Applicable

Detailed Description:
The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
Masking: Double (Participant, Investigator)
Masking Description: Both the participants and study investigators will be masked to the randomization schedule of the contact lenses used.
Primary Purpose: Treatment
Official Title: Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : April 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: somofilcon A 1 day test lens
Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.
Device: somofilcon A 1 day test lens
Contact lens
Other Names:
  • somofilcon A daily disposable test soft contact lens
  • Invigor I
  • Test lens

Device: somofilcon A 1 day control lens
Contact lens
Other Names:
  • somofilcon A daily disposable control soft contact lens
  • Select 1-Day
  • Control lens

Active Comparator: somofilcon A 1 day control lens
Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.
Device: somofilcon A 1 day test lens
Contact lens
Other Names:
  • somofilcon A daily disposable test soft contact lens
  • Invigor I
  • Test lens

Device: somofilcon A 1 day control lens
Contact lens
Other Names:
  • somofilcon A daily disposable control soft contact lens
  • Select 1-Day
  • Control lens




Primary Outcome Measures :
  1. Comfort [ Time Frame: up to 1 week ]
    Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)

  2. Preference [ Time Frame: up to 1 week ]
    Overall lens that subject prefers or no preference

  3. Vision [ Time Frame: Up to 1 week ]
    Visual acuity measured in logMAR

  4. Subjective Vision [ Time Frame: up to 1 week ]
    Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)

  5. Corneal Staining [ Time Frame: up to 1 week ]
    Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps

  6. Conjunctival Staining [ Time Frame: up to 1 week ]
    Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has had a self-reported oculo-visual examination in the last two years;
  • Has read, understood, and signed the information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
  • Must be able to achieve 20/30 or better (in each eye) with the study lenses;
  • Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
  • Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
  • Has no more than 0.75 diopters of refractive astigmatism;
  • Has clear corneas and no active* ocular disease;
  • Has not worn lenses for at least 12 hours before the examination.

Exclusion Criteria:

  • Is presently participating in any other clinical or research study including eye related clinical or research study;
  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
  • Has any known sensitivity to fluorescein dye or products to be used in the study.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  • Is aphakic.
  • Has undergone corneal refractive surgery.
  • Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

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): NCT03372551


Locations
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Canada, Ontario
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Coopervision, Inc.
  Study Documents (Full-Text)

Documents provided by Coopervision, Inc.:

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT03372551    
Other Study ID Numbers: CV-16-43
First Posted: December 13, 2017    Key Record Dates
Results First Posted: May 29, 2019
Last Update Posted: July 23, 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: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases