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

January 30, 2017 updated by: Coopervision, Inc.
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico D.F., Mexico
        • Optometry Clinic, National Autonomous University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • methafilcon A
Device: Green (CVI-test)
contact lens
Other Names:
  • methafilcon A
Other: 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 Names:
  • methafilcon A
Device: Grey (CVI-test)
contact lens
Other Names:
  • methafilcon A
Other: 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 Names:
  • methafilcon A
Device: Jade (CVI-test)
contact lens
Other Names:
  • methafilcon A
Other: 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 Names:
  • methafilcon A
Device: Blue (CVI-test)
contact lens
Other Names:
  • methafilcon A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 minutes
Comfort
Time Frame: Baseline
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Baseline
Comfort
Time Frame: 20 minutes
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
20 minutes
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
Baseline
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
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coopervision, Inc.

Investigators

  • Principal Investigator: Ruben Velazquez Guerrero, MSc FIACLE, School of Optometry, National Autonomous University (UNAM), Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-MKTG-51

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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