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A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

Not Applicable
Completed
Conditions
Myopia
Refractive Error
Registration Number
NCT01782482
Lead Sponsor
Alcon Research
Brief Summary

The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
574
Inclusion Criteria
  • Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
  • Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
  • Manifest cylinder less than or equal to 0.75 diopter in each eye.
  • Wear contact lenses within protocol-defined specifications.
  • Require spherical contact lenses within the available range of powers.
  • Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
  • Any eye condition that contraindicates contact lens wear.
  • Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • Moderate or severe ocular findings upon examination.
  • Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
  • Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
  • Previous corneal or refractive surgery or irregular cornea.
  • Eye injury or surgery within the last 6 months (excluding placement of punctal plugs).
  • Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
  • History of intolerance or hypersensitivity to any component of the test articles.
  • Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Subjective Rating of Overall SatisfactionDay 7

Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.

Secondary Outcome Measures
NameTimeMethod
Positive Purchase IntentDay 7

As reported on a questionnaire in response to, "Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses?" The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing "Definitely would purchase" or "Probably would purchase."

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