Myopia
Conditions
Keywords
contact lenses, color contact lenses, myopia
Brief summary
The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.
Detailed description
Eligible participants were randomized at Visit 1 (Screening) to receive 1 of the 2 investigational products (1:1 assignment). Between Visit 1 and Visit 2, participants wore their habitual AIR OPTIX® AQUA lenses. Investigational products were dispensed at Visit 2 (Baseline), after which participants were asked to return for 2 additional visits: Visit 3 (Day 14) and Visit 4 (Day 28).
Interventions
Silicone hydrogel contact lens with color
Silicone hydrogel contact lens
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity ≥ 20/25 in each eye. * Manifest cylinder less than or equal to 0.75 diopter (D) (within the previous year) in each eye. * Successful wear of AIR OPTIX® AQUA soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. * Willing to sign an Informed Consent form. If under legal age of consent, legally authorized representative must also sign an Informed Consent form. * 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 (OTC) or prescribed topical ocular medications within 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 that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions. * Ocular or intra-ocular surgery within the previous 12 months (excluding placement of punctal plugs). * Use of medications contributing to dry eye or ocular irritation unless on a stable dosing regimen for a minimum of 30 days prior to study entry and able to remain on stable regimen throughout the study. * Participation in any investigational clinical study within previous 30 days. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Same Fit in Both Eyes | Up to Day 28 | Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. Same fit was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit. |
Secondary
| 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. |
Participant flow
Recruitment details
Participants were recruited from 15 study centers located in the United States.
Pre-assignment details
Of the 258 participants enrolled, 7 participants did not receive study lenses. This reporting group includes all enrolled and randomized participants who received study lenses (251).
Participants by arm
| Arm | Count |
|---|---|
| AIR OPTIX® COLORS Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. | 125 |
| AIR OPTIX® AQUA Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. | 126 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Subject decision | 2 | 0 |
Baseline characteristics
| Characteristic | AIR OPTIX® COLORS | AIR OPTIX® AQUA | Total |
|---|---|---|---|
| Age, Customized 16-17 years | 10 participants | 5 participants | 15 participants |
| Age, Customized 18-64 years | 115 participants | 119 participants | 234 participants |
| Age, Customized ≥ 65 years | 0 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 92 Participants | 91 Participants | 183 Participants |
| Sex: Female, Male Male | 33 Participants | 35 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 125 | 0 / 126 |
| serious Total, serious adverse events | 0 / 125 | 0 / 126 |
Outcome results
Primary
Percentage of Subjects With Same Fit in Both Eyes
Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. Same fit was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit.
Time frame: Up to Day 28
Population: ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). 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, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIR OPTIX® COLORS | Percentage of Subjects With Same Fit in Both Eyes | Day 14 (n=121,126) | 99.2 percentage of participants |
| AIR OPTIX® COLORS | Percentage of Subjects With Same Fit in Both Eyes | Day 28 (n=122, 124) | 99.2 percentage of participants |
| AIR OPTIX® AQUA | Percentage of Subjects With Same Fit in Both Eyes | Day 14 (n=121,126) | 100 percentage of participants |
| AIR OPTIX® AQUA | Percentage of Subjects With Same Fit in Both Eyes | Day 28 (n=122, 124) | 99.2 percentage of participants |
Secondary
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: ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). 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, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIR OPTIX® COLORS | Subjective Rating of Overall Comfort | Day 14 (n=122, 126) | 8.4 units on a scale | Standard Deviation 1.8 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Comfort | Day 28 (n=122, 125) | 8.5 units on a scale | Standard Deviation 1.4 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Comfort | Day 14 (n=122, 126) | 8.9 units on a scale | Standard Deviation 1.3 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Comfort | Day 28 (n=122, 125) | 8.9 units on a scale | Standard Deviation 1.4 |