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OpenTrials
Completed

NCT Number: NCT02299869

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Optometry Clinic, National Autonomous University

Mexico City, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Verde (Competitor-control)

Device

contact lens

Other names: methafilcon A

Green (CVI-test)

Device

contact lens

Other names: methafilcon A

Cinza (Competitor-control)

Device

contact lens

Other names: methafilcon A

Grey (CVI-test)

Device

contact lens

Other names: methafilcon A

Esmeralda (Competitor-control)

Device

contact lens

Other names: methafilcon A

Jade (CVI-test)

Device

contact lens

Other names: methafilcon A

Azul (Competitor-control)

Device

contact lens

Other names: methafilcon A

Blue (CVI-test)

Device

contact lens

Other names: methafilcon A

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2014
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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