Myopia
Conditions
Keywords
Lens fit, contact lenses, myopia
Brief summary
The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the no re-fit criteria in each treatment group.
Interventions
DEVICELotrafilcon B sphere modified design contact lenses
DEVICELotrafilcon B sphere contact lenses
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign an Informed Consent Document; * Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule; * Manifest cylinder less than or equal to 0.75 D; * Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance; * Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses; * Wearing spherical AIR OPTIX® AQUA lenses in both eyes for at least 3 months (at least 8 hours per day, at least 5 days per week), wearing the habitual lenses for a minimum of 4 hours prior to the baseline study visit, and achieving an acceptable or optimal fit at baseline visit with habitual lenses in both eyes; * Other protocol-defined criteria may apply.
Exclusion criteria
* Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week); * Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment; * 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; * History of herpetic keratitis; * History of corneal or refractive surgery or irregular cornea; * A pathologically dry eye that precludes contact lens wear; * Monocular (only one eye with functional vision); * Monovision correction; * History of intolerance or hypersensitivity to any component of the test articles or associated materials; * Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days; * Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment; * Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes | Dispense (Day 0), Week 1 | With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of no re-fit, an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage. |
Participant flow
Recruitment details
Subjects were recruited from 5 study centers located in the US.
Pre-assignment details
Of the 134 enrolled, 2 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (132).
Participants by arm
| Arm | Count |
|---|---|
| AOA Modified Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days | 66 |
| AOA Sphere Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days | 66 |
| Total | 132 |
Baseline characteristics
| Characteristic | AOA Modified | AOA Sphere | Total |
|---|---|---|---|
| Age, Continuous | 29.9 years STANDARD_DEVIATION 9.5 | 31.3 years STANDARD_DEVIATION 9.8 | 30.6 years STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 45 Participants | 50 Participants | 95 Participants |
| Sex: Female, Male Male | 21 Participants | 16 Participants | 37 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 / 134 | 0 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 134 | 0 / 66 | 0 / 66 |
Outcome results
Primary
Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes
With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of no re-fit, an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.
Time frame: Dispense (Day 0), Week 1
Population: This analysis population includes all randomized and treated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AOA Modified | Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes | Dispense (Day 0) | 100.0 percentage of subjects |
| AOA Modified | Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes | Week 1 | 100.0 percentage of subjects |
| AOA Sphere | Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes | Dispense (Day 0) | 100.0 percentage of subjects |
| AOA Sphere | Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes | Week 1 | 100.0 percentage of subjects |