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

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Grey (CVI-test); Device: Blue (CVI-test); Device: Esmeralda (Competitor-control); Device: Cinza (Competitor-control); Device: Jade (CVI-test); Device: Green (CVI-test); Device: Verde (Competitor-control); Device: Azul (Competitor-control)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02299869

EX-MKTG-51

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 4 patient groups

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

Other group

Description:

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

Treatment:

Device: Verde (Competitor-control)

Device: Green (CVI-test)

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

Other group

Description:

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

Treatment:

Device: Cinza (Competitor-control)

Device: Grey (CVI-test)

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

Other group

Description:

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

Treatment:

Device: Jade (CVI-test)

Device: Esmeralda (Competitor-control)

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

Other group

Description:

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

Treatment:

Device: Azul (Competitor-control)

Device: Blue (CVI-test)