Myopia
Conditions
Keywords
Contact lens, Vision care, Daily wear, Color contact lens
Brief summary
The purpose of this study is to evaluate the comfort of color contact lenses in a population of clear contact lens wearers who have an interest in wearing color contact lenses.
Interventions
DEVICELotrafilcon B contact lenses with color printing
DEVICEPhemfilcon A contact lenses with color printing
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 to sign an Informed Consent Document or Assent, if applicable. * Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses. * Manifest cylinder (at screening) less than or equal to 0.75 diopters (D) in each eye. * Successful wear of clear/handling tint, single-vision spherical, bi-weekly/ monthly replacement soft contact lenses in both eyes during the past 2 months for a minimum of 5 days per week and 8 hours per day. * Requires spherical contact lenses within the available range of powers (i.e.,-1.50D to -5.00D in 0.25D steps). * Interested in wearing contact lenses that change the appearance of the color of the eyes. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current). * History of herpetic keratitis. * Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear, except for rewetting drops. * Corneal vascularization greater than 1 millimeter (mm) of penetration. * 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. * Monovision and monocular (only 1 eye with functional vision) or fit with only 1 lens. * Anisometropia ≥1.50D (study contact lens prescription). * History of intolerance or hypersensitivity to any component of the test articles. * Eye injury or ocular or intra-ocular surgery within the last 6 months (excluding placement of punctal plugs). * Participation in any clinical study within 30 days of Visit 1. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Comfort Likert Response at Day 30 | Day 30 | Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Comfort Likert Response at Day 14 | Day 14 | Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only. |
| Lens Comfort 1-10 Scale Response | Day 30 | Subject was instructed, Please rate your comfort with the study lenses, using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together. |
Participant flow
Recruitment details
Subjects were recruited from 10 Study Centers located in the US.
Pre-assignment details
Of the 151 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (150).
Participants by arm
| Arm | Count |
|---|---|
| AIR OPTIX COLORS Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days. | 72 |
| FreshLook COLORBLENDS Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement. | 74 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Randomized in Error | 1 | 0 |
| Overall Study | Sponsor Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | AIR OPTIX COLORS | FreshLook COLORBLENDS | Total |
|---|---|---|---|
| Age, Continuous | 29.9 years STANDARD_DEVIATION 7.91 | 29.4 years STANDARD_DEVIATION 7.62 | 29.7 years STANDARD_DEVIATION 7.74 |
| Sex: Female, Male Female | 67 Participants | 60 Participants | 127 Participants |
| Sex: Female, Male Male | 5 Participants | 14 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 151 | 0 / 144 | 0 / 148 |
| serious Total, serious adverse events | 0 / 151 | 0 / 144 | 0 / 148 |
Outcome results
Primary
Lens Comfort Likert Response at Day 30
Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only.
Time frame: Day 30
Population: This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIR OPTIX COLORS | Lens Comfort Likert Response at Day 30 | 81.4 percentage of subjects |
Secondary
Lens Comfort 1-10 Scale Response
Subject was instructed, Please rate your comfort with the study lenses, using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together.
Time frame: Day 30
Population: This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIR OPTIX COLORS | Lens Comfort 1-10 Scale Response | 8.0 units on a scale | Standard Deviation 1.99 |
| FreshLook COLORBLENDS | Lens Comfort 1-10 Scale Response | 7.3 units on a scale | Standard Deviation 2.19 |
Secondary
Lens Comfort Likert Response at Day 14
Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only.
Time frame: Day 14
Population: This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIR OPTIX COLORS | Lens Comfort Likert Response at Day 14 | 89.9 percentage of subjects |