A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 574
- Primary Endpoint
- Subjective Rating of Overall Satisfaction
Study Overview
Brief Summary
The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
AIR OPTIX® COLORS
Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Intervention: Lotrafilcon B contact lens with color (Device)
FRESHLOOK® COLORBLENDS
Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Intervention: Phemfilcon A contact lens with color (Device)
Outcomes
Primary Outcomes
Subjective Rating of Overall Satisfaction
Time Frame: 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 Outcomes
- Positive Purchase Intent(Day 7)