Myopia
Conditions
Keywords
contact lenses, color contact lenses, myopia
Brief summary
The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .
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
* Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document. * Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye. * Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye. * Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day. * History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS). * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study. * Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis). * Monovision, monocular (only one eye with functional vision) or fit with only one lens. * History of intolerance or hypersensitivity to any component of the test articles. * Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops). * Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, other complications; and any corneal infiltrates. * Current or history of ocular infection, severe inflammation, or disease within previous 6 months. * Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions. * Participation in any investigational clinical study within previous 30 days. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Rating of Overall Comfort | Up to Day 28 | Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Rating of Overall Vision | Up to Day 28 | Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating. |
| Proportion of Subjects Preferring Study Lens (Strongly or Somewhat) | Day 28 | Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens. |
Participant flow
Recruitment details
Participants were recruited from 24 study centers located in the United States.
Pre-assignment details
Of the 370 participants enrolled and randomized, 4 did not meet inclusion/exclusion criteria, 2 were lost to follow-up, and 1 declined participation. This reporting group includes all participants exposed to the study product (363).
Participants by arm
| Arm | Count |
|---|---|
| AIR OPTIX® COLORS Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. | 178 |
| FRESHLOOK® COLORBLENDS Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. | 185 |
| Total | 363 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 5 |
| Overall Study | No longer had transportation | 0 | 1 |
| Overall Study | Noncompliance | 0 | 1 |
| Overall Study | Subject decision | 1 | 1 |
Baseline characteristics
| Characteristic | AIR OPTIX® COLORS | FRESHLOOK® COLORBLENDS | Total |
|---|---|---|---|
| Age, Customized 16-17 years | 9 participants | 10 participants | 19 participants |
| Age, Customized 18-64 years | 167 participants | 174 participants | 341 participants |
| Age, Customized ≥65 years | 2 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 164 Participants | 166 Participants | 330 Participants |
| Sex: Female, Male Male | 14 Participants | 19 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 178 | 0 / 185 |
| serious Total, serious adverse events | 1 / 178 | 2 / 185 |
Outcome results
Primary
Subjective Rating of Overall Comfort
Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Time frame: Up to Day 28
Population: The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIR OPTIX® COLORS | Subjective Rating of Overall Comfort | Day 28 (n=176,176) | 8.7 Units on a scale | Standard Deviation 1.7 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Comfort | Day 14 (n=175,181) | 8.7 Units on a scale | Standard Deviation 1.7 |
| FRESHLOOK® COLORBLENDS | Subjective Rating of Overall Comfort | Day 14 (n=175,181) | 8.6 Units on a scale | Standard Deviation 1.8 |
| FRESHLOOK® COLORBLENDS | Subjective Rating of Overall Comfort | Day 28 (n=176,176) | 8.5 Units on a scale | Standard Deviation 1.7 |
Secondary
Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)
Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.
Time frame: Day 28
Population: The analysis population includes all enrolled and dispensed participants who had at least 1 study visit after being dispensed the study lenses. No imputation was used for missing values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIR OPTIX® COLORS | Proportion of Subjects Preferring Study Lens (Strongly or Somewhat) | 54.3 Percentage of participants |
| FRESHLOOK® COLORBLENDS | Proportion of Subjects Preferring Study Lens (Strongly or Somewhat) | 45.2 Percentage of participants |
Secondary
Subjective Rating of Overall Vision
Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Time frame: Up to Day 28
Population: The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIR OPTIX® COLORS | Subjective Rating of Overall Vision | Day 14 (n=175,181) | 8.8 Units on a scale | Standard Deviation 1.6 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Vision | Day 28 (n=176,177) | 8.9 Units on a scale | Standard Deviation 1.5 |
| FRESHLOOK® COLORBLENDS | Subjective Rating of Overall Vision | Day 14 (n=175,181) | 8.7 Units on a scale | Standard Deviation 1.5 |
| FRESHLOOK® COLORBLENDS | Subjective Rating of Overall Vision | Day 28 (n=176,177) | 8.7 Units on a scale | Standard Deviation 1.5 |