Myopia, Refractive Error
Conditions
Keywords
Color contact lenses, Refractive error, Myopia
Brief summary
The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.
Interventions
Silicone hydrogel contact lens with color
Hydrogel contact lens with color
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Recruitment details
Participants were recruited from 30 study centers, located in the United States.
Pre-assignment details
Of the 574 enrolled, 13 participants did not meet all inclusion/exclusion criteria and were exited as screen failures. This reporting group includes all enrolled and randomized participants (561).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 278 |
| 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. | 274 |
| Total | 552 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Habitually wearing toric lens OS | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Randomized in Error | 2 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | AIR OPTIX® COLORS | FRESHLOOK® COLORBLENDS | Total |
|---|---|---|---|
| Age, Customized 16-17 years | 11 participants | 11 participants | 22 participants |
| Age, Customized 18-64 years | 267 participants | 263 participants | 530 participants |
| Age, Customized ≥65 years | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 247 Participants | 254 Participants | 501 Participants |
| Sex: Female, Male Male | 31 Participants | 20 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 276 | 0 / 274 |
| serious Total, serious adverse events | 0 / 276 | 0 / 274 |
Outcome results
Primary
Subjective Rating of Overall Satisfaction
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.
Time frame: Day 7
Population: The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIR OPTIX® COLORS | Subjective Rating of Overall Satisfaction | 7.45 Units on a scale | Standard Error 0.17 |
| FRESHLOOK® COLORBLENDS | Subjective Rating of Overall Satisfaction | 6.91 Units on a scale | Standard Error 0.17 |
Secondary
Positive Purchase Intent
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.
Time frame: Day 7
Population: The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIR OPTIX® COLORS | Positive Purchase Intent | 51.7 Percentage of participants |
| FRESHLOOK® COLORBLENDS | Positive Purchase Intent | 42.5 Percentage of participants |