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Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

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ClinicalTrials.gov Identifier: NCT03974802
Recruitment Status : Active, not recruiting
First Posted : June 5, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE May 14, 2019
Actual Primary Completion Date July 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Lens Centration [ Time Frame: Up to 4 weeks ]
    Lens Centration (0=centered, 1=slightly decentered/2=substantially decentered)
  • Corneal Coverage [ Time Frame: Up to 4 weeks ]
    Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
  • Percentage of Lens Tightness [ Time Frame: Up to 4 weeks ]
    Lens Tightness: Push Up Test (measured by 0% to 100%, 50% = optimum)
  • Grade of Overage Fit Acceptance [ Time Frame: Up to 4 weeks ]
    Overall fit acceptance - Graded 0-4 (0=should not be worn, 4=perfect)
  • Post-Blink Movement [ Time Frame: Up to 4 weeks ]
    Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03974802 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Average Number of Days Lenses Worn in a Week [ Time Frame: Up to 4 weeks ]
    Average number of days lenses are worn during a week - measured in days/week)
  • Average Daily Wearing Time [ Time Frame: Up to 4 weeks ]
    Typical time of day when lenses inserted and removed - measured by time of day to nearest half hour )
  • Average Number of Hours of Wear Per Day [ Time Frame: Up to 4 weeks ]
    Average number of hours lenses are worn / day - measured in hours/day
  • Average Comfortable Wearing Time [ Time Frame: Up to 4 weeks ]
    Typical time of day when subject first experiences lens awareness or irritation - tick box w/time recorded started from time of day to nearest half hour when first aware).
  • Typical Removal Time [ Time Frame: Up to 4 weeks ]
    Typical time of day when subject removes the lens - measured by time of day to nearest half hour
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
Official Title  ICMJE Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
Brief Summary The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.
Masking: None (Open Label)
Masking Description:
Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses.
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE
  • Device: somofilcon A contact lens
    Contact Lens
    Other Names:
    • Clariti Elite
    • Habitual lens
  • Device: fanfilcon A contact lens
    Contact Lens
    Other Names:
    • Avaira Vitality
    • Test lens
Study Arms  ICMJE Experimental: somofilcon A (habitual) lens, then fanfilcon A (test) lens
Participants are habitual wearers of somofilcon A lens and refitted with fanfilcon A lens.
Interventions:
  • Device: somofilcon A contact lens
  • Device: fanfilcon A contact lens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 21, 2019)
41
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
40
Estimated Study Completion Date  ICMJE September 2019
Actual Primary Completion Date July 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self‐reported visual exam in the last two years
  • Is an adapted soft contact lens wearer
  • Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
  • Have no less than ‐0.75D of astigmatism in both eyes.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Patient contact lens refraction should fit within the available parameters of the study lenses.
  • Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion Criteria:

  • Has a CL prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder of ≥ 1.00D in either eye.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  • Presence of clinically significant (grade 2‐4) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
  • Slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings
    • Pterygium, pinguecula, or corneal scars within the visual axis
    • Neovascularization > 0.75 mm in from of the limbus
    • Giant papillary conjunctivitis (GCP) worse than grade 1
    • Anterior uveitis or iritis (past or present)
    • Seborrheic eczema, Seborrheic conjunctivitis
    • History of corneal ulcers or fungal infections
    • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974802
Other Study ID Numbers  ICMJE EX-MKTG-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Coopervision, Inc.
Study Sponsor  ICMJE Coopervision, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ruben Velázquez Guerrero, MSc., FIACLE School of Optometry, National Autonomous University (UNAM), Mexico City
PRS Account Coopervision, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP