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N/A N=40 Randomized Double-blind Other

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

Myopia

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Cosmetic Appearance Preference — 8; 9; 4; 5 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
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) (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Oct 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Cosmetic Appearance Preference
8; 9; 4; 5; 2; 1
PRIMARY
Comfort
9.3; 8.3; 8.6; 8.1; 7.5; 8.0
PRIMARY
Comfort
9.3; 8.3; 8.6; 8.1; 7.5; 8.0
PRIMARY
Comfort Preference
8; 4; 4; 4; 2; 6
PRIMARY
Comfort Preference
8; 4; 4; 4; 2; 6

Summary

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

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02299869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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