A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
- Conditions
- MyopiaRefractive 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
- 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.
- 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
Name Time Method Subjective Rating of Overall Satisfaction Day 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
Name Time Method Positive Purchase Intent Day 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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