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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.

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.

Condition or disease Intervention/treatment Phase
Myopia Device: somofilcon A contact lens Device: fanfilcon A contact lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
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
Official Title: Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
Actual Study Start Date : May 14, 2019
Actual Primary Completion Date : July 24, 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: somofilcon A (habitual) lens, then fanfilcon A (test) lens
Participants are habitual wearers of somofilcon A lens and refitted with fanfilcon A lens.
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




Primary Outcome Measures :
  1. Lens Centration [ Time Frame: Up to 4 weeks ]
    Lens Centration (0=centered, 1=slightly decentered/2=substantially decentered)

  2. Corneal Coverage [ Time Frame: Up to 4 weeks ]
    Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  3. Percentage of Lens Tightness [ Time Frame: Up to 4 weeks ]
    Lens Tightness: Push Up Test (measured by 0% to 100%, 50% = optimum)

  4. Grade of Overage Fit Acceptance [ Time Frame: Up to 4 weeks ]
    Overall fit acceptance - Graded 0-4 (0=should not be worn, 4=perfect)

  5. Post-Blink Movement [ Time Frame: Up to 4 weeks ]
    Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)


Secondary Outcome Measures :
  1. 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)

  2. 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 )

  3. 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

  4. 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).

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03974802


Locations
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Mexico
Optometry Clinic, National Autonomous University
Mexico City, Mexico, 54090
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Ruben Velázquez Guerrero, MSc., FIACLE School of Optometry, National Autonomous University (UNAM), Mexico City

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT03974802     History of Changes
Other Study ID Numbers: EX-MKTG-101
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases