Myopia, Astigmatism
Conditions
Keywords
contact lenses, myopia, astigmatism
Brief summary
The purpose of this study is to evaluate differences in the comfort at the end of the month between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft contact lens wearers.
Interventions
Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription
Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign written informed consent document. * Currently wearing weekly/biweekly or monthly sphere or toric soft contact lenses (NOT including AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR OPTIX for Astigmatism, Biofinity Sphere, Biofinity Toric, or ProClear Toric soft contact lenses) bilaterrally (in both eyes) and have worn these lenses for at least 3 months, daily wear use only (no extended wear). * Symptomatic for contact lens-related ocular discomfort at the end of the lens wearing day. * Current contact lens prescription within the available parameters of both study products. * Able to achieve visual acuity (VA) of at least 6/7.5 (20/25) in each eye with study lenses in the available parameters. * Willing to wear study lenses for at least 4 hours/day and at least 5 days/week for the 1 month trial period. * Willing and able to follow instructions, study procedures and maintain the appointment schedule. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft contact lenses. * Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study. * Recent (within 7 days of enrollment) or current ocular infections, active ocular inflammation, glaucoma or preauricular lymphadenopathy. * A history of ocular surgery/trauma within the last 6 months. * Topical or systemic antibiotics use within 7 days of enrollment. * Topical ocular or systemic corticosteroids use within 14 days of enrollment. * Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Likert Response: I Can Comfortably Wear my Lenses at Day 30 | Baseline, Day 30 | Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent. |
Participant flow
Recruitment details
Participants were recruited from 22 sites located in the United States.
Pre-assignment details
Of the 398 enrolled, 17 participants were exited as screen failures. This reporting group includes all participants who provided informed consent, were randomized, and utilized the study lenses (381).
Participants by arm
| Arm | Count |
|---|---|
| Air Optix Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis | 193 |
| Biofinity Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis | 188 |
| Total | 381 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Investigator decision | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Poor comfort of study lenses | 0 | 2 |
| Overall Study | Subject decision unrelated to AE | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Air Optix | Biofinity | Total |
|---|---|---|---|
| Age, Continuous | 32.7 years STANDARD_DEVIATION 9.1 | 33.1 years STANDARD_DEVIATION 10.5 | 32.9 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 143 Participants | 131 Participants | 274 Participants |
| Sex: Female, Male Male | 50 Participants | 57 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 193 | 0 / 188 |
| serious Total, serious adverse events | 1 / 193 | 1 / 188 |
Outcome results
Primary
Change From Baseline in Likert Response: I Can Comfortably Wear my Lenses at Day 30
Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.
Time frame: Baseline, Day 30
Population: This analysis population includes all participants who completed the protocol and had no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Air Optix | Change From Baseline in Likert Response: I Can Comfortably Wear my Lenses at Day 30 | Baseline | 6.1 units on a scale | Standard Deviation 2.2 |
| Air Optix | Change From Baseline in Likert Response: I Can Comfortably Wear my Lenses at Day 30 | Change from Baseline at Day 30 | 1.5 units on a scale | Standard Deviation 2.8 |
| Biofinity | Change From Baseline in Likert Response: I Can Comfortably Wear my Lenses at Day 30 | Baseline | 6.3 units on a scale | Standard Deviation 2.1 |
| Biofinity | Change From Baseline in Likert Response: I Can Comfortably Wear my Lenses at Day 30 | Change from Baseline at Day 30 | 1.4 units on a scale | Standard Deviation 2.7 |