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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Verde (Competitor-control)
Green (CVI-test)
Cinza (Competitor-control)
Grey (CVI-test)
Esmeralda (Competitor-control)
Jade (CVI-test)
Azul (Competitor-control)
Blue (CVI-test)
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Optometry Clinic, National Autonomous University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Group 1 - Verde (Competitor-control) vs. Green (CVI-test)

Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)

Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)

Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)

Arm Description

Each subject was randomized to wear the test and control lenses contralaterally.

Each subject was randomized to wear the test and control lenses contralaterally.

Each subject was randomized to wear the test and control lenses contralaterally.

Each subject was randomized to wear the test and control lenses contralaterally.

Outcomes

Primary Outcome Measures

Cosmetic Appearance Preference
Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference
Comfort
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Comfort
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Comfort Preference
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
Comfort Preference
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

Secondary Outcome Measures

Full Information

First Posted
November 20, 2014
Last Updated
January 30, 2017
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02299869
Brief Title
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
Official Title
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Verde (Competitor-control) vs. Green (CVI-test)
Arm Type
Other
Arm Description
Each subject was randomized to wear the test and control lenses contralaterally.
Arm Title
Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)
Arm Type
Other
Arm Description
Each subject was randomized to wear the test and control lenses contralaterally.
Arm Title
Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)
Arm Type
Other
Arm Description
Each subject was randomized to wear the test and control lenses contralaterally.
Arm Title
Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)
Arm Type
Other
Arm Description
Each subject was randomized to wear the test and control lenses contralaterally.
Intervention Type
Device
Intervention Name(s)
Verde (Competitor-control)
Other Intervention Name(s)
methafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Green (CVI-test)
Other Intervention Name(s)
methafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Cinza (Competitor-control)
Other Intervention Name(s)
methafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Grey (CVI-test)
Other Intervention Name(s)
methafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Esmeralda (Competitor-control)
Other Intervention Name(s)
methafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Jade (CVI-test)
Other Intervention Name(s)
methafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Azul (Competitor-control)
Other Intervention Name(s)
methafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Blue (CVI-test)
Other Intervention Name(s)
methafilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Cosmetic Appearance Preference
Description
Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference
Time Frame
20 minutes
Title
Comfort
Description
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Time Frame
Baseline
Title
Comfort
Description
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Time Frame
20 minutes
Title
Comfort Preference
Description
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
Time Frame
Baseline
Title
Comfort Preference
Description
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
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Velazquez Guerrero, MSc FIACLE
Organizational Affiliation
School of Optometry, National Autonomous University (UNAM), Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Clinic, National Autonomous University
City
Mexico D.F.
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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