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Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.

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ClinicalTrials.gov Identifier: NCT02299869
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : August 24, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Description
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Brief Summary:
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses

Condition or disease Intervention/treatment Phase
Myopia Device: Verde (Competitor-control) Device: Green (CVI-test) Device: Cinza (Competitor-control) Device: Grey (CVI-test) Device: Esmeralda (Competitor-control) Device: Jade (CVI-test) Device: Azul (Competitor-control) Device: Blue (CVI-test) Not Applicable

Detailed Description:
Each lens pair comparison will require two visits over two days, as follows: Visits: V1 (lens dispensing), V2 (20 minutes post lens settling). Each subject will be randomized to wear the test and control lenses in a series of four short fitting comparisons.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
Study Start Date : October 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Arms and Interventions
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Arm Intervention/treatment
Group 1 - Verde (Competitor-control) vs. Green (CVI-test)
Each subject was randomized to wear the test and control lenses contralaterally.
 Device: Verde (Competitor-control)
contact lens
Other Name: methafilcon A

Device: Green (CVI-test)
contact lens
Other Name: methafilcon A
Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)
Each subject was randomized to wear the test and control lenses contralaterally.
 Device: Cinza (Competitor-control)
contact lens
Other Name: methafilcon A

Device: Grey (CVI-test)
contact lens
Other Name: methafilcon A
Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)
Each subject was randomized to wear the test and control lenses contralaterally.
 Device: Esmeralda (Competitor-control)
contact lens
Other Name: methafilcon A

Device: Jade (CVI-test)
contact lens
Other Name: methafilcon A
Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)
Each subject was randomized to wear the test and control lenses contralaterally.
 Device: Azul (Competitor-control)
contact lens
Other Name: methafilcon A

Device: Blue (CVI-test)
contact lens
Other Name: methafilcon A


Outcome Measures
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Primary Outcome Measures :
  1. Cosmetic Appearance Preference [ Time Frame: 20 minutes ]
    Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference

  2. Comfort [ Time Frame: Baseline ]
    Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).

  3. Comfort [ Time Frame: 20 minutes ]
    Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).

  4. Comfort Preference [ Time Frame: Baseline ]
    Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference

  5. Comfort Preference [ Time Frame: 20 minutes ]
    Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference


Eligibility Criteria
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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 wearer of spherical soft contact lenses.
  • Has a contact lens spherical prescription between - 1.00 and - 10.00 (inclusive).
  • Has a spectacle cylinder up to 0.75 diopter (D) in each eye
  • Can achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
  • Has clear corneas and no active ocular disease.
  • Has read, understood and signed the information consent letter.
  • Is willing to wear his/hers spectacles over the study contact lenses.
  • Is willing to comply with the wear schedule.
  • Is willing to comply with the visit schedule.

Exclusion Criteria:

  • Has never worn contact lenses before.
  • Currently wears rigid gas permeable contact lenses.
  • Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
  • Has a contact lens prescription outside the range of - 1.00 to -10.00D.
  • Has a spectacle cylinder ≥1.00D of cylinder in either eye.
  • Does not have a pair of corrective spectacles at the time of the visit.
  • Cannot achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
  • Presence of clinically significant (grade > 2.0, scale 0-4) 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.
Contacts and Locations
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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): NCT02299869


Locations
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Mexico
Optometry Clinic, National Autonomous University
Mexico D.F., Mexico
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Ruben Velazquez Guerrero, MSc FIACLE School of Optometry, National Autonomous University (UNAM), Mexico
More Information
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02299869    
Other Study ID Numbers: EX-MKTG-51
First Posted: November 24, 2014    Key Record Dates
Results First Posted: August 24, 2016
Last Update Posted: March 10, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases