Refractive Error, Myopia, Hyperopia, Astigmatism, Presbyopia
Conditions
Keywords
Refractive error, Myopia, Hyperopia, Astigmatism, Presbyopia, Contact lenses, Contact lens solution, Comfort
Brief summary
The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to Acuvue® Oasys® lenses cared for with habitual MPDS.
Detailed description
Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.
Interventions
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
DEVICEOPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)
Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions
DEVICEHabitual Multi-Purpose Solution (MPS)
Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign informed consent. * Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol. * Willing to wear contact lenses on a daily wear basis for the duration of the study. * Currently using a multi-purpose solution, as specified in protocol. * Vision correctable to 20/30 (Snellen) or better in each eye at distance at Visit 1. * Willing to follow the study procedures and visit schedule. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Currently wearing Air Optix, Acuvue Oasys, or Acuvue Advance brand of lenses. * Currently using any Opti-Free brand of multi-purpose solution. * Must wear contact lenses on an extended wear (overnight) basis during the study. * Known sensitivity or intolerance to POLYQUAD® or ALDOX preserved lens care products. * Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear. * Use of additional lens care products other than a multi-purpose solution within 7 days prior to Visit 1. * Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of contact lens rewetting drops, within 7 days prior to Visit 1. * Any abnormal ocular condition observed during the Visit 1 slit-lamp examination. * Current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to Visit 1. * Ocular surgery within the 12 months prior to Visit 1. * Any systemic diseases at Visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions. * Participation in any clinical study within 30 days of Visit 1. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Likert Scale Questionnaire Item: I Can Comfortably Wear my Lenses | Day 30; after 4 hours of lens wear | Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree. |
Participant flow
Recruitment details
Subjects were recruited from 22 study sites located in the US.
Pre-assignment details
Of the 387 enrolled, 15 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (372).
Participants by arm
| Arm | Count |
|---|---|
| Air Optix/OFPM Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system | 187 |
| Acuvue Oasys/Habitual MPS Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system | 184 |
| Total | 371 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Decision Unrelated to an Adverse Event | 1 | 0 |
| Overall Study | Failed slit lamp exam | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Non-Compliance | 1 | 1 |
| Overall Study | Product not available | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Air Optix/OFPM | Acuvue Oasys/Habitual MPS | Total |
|---|---|---|---|
| Age, Continuous | 32.4 years STANDARD_DEVIATION 10.12 | 35.0 years STANDARD_DEVIATION 11.14 | 33.7 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 141 Participants | 142 Participants | 283 Participants |
| Sex: Female, Male Male | 46 Participants | 42 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 187 | 0 / 184 |
| serious Total, serious adverse events | 0 / 187 | 0 / 184 |
Outcome results
Primary
Likert Scale Questionnaire Item: I Can Comfortably Wear my Lenses
Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.
Time frame: Day 30; after 4 hours of lens wear
Population: This analysis population includes all subjects who were randomized and received study regimen (test or control) with a Day 30 response to this Likert item.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Air Optix/OFPM | Likert Scale Questionnaire Item: I Can Comfortably Wear my Lenses | 4.2 units on a scale | Standard Deviation 0.9 |
| Acuvue Oasys/Habitual MPS | Likert Scale Questionnaire Item: I Can Comfortably Wear my Lenses | 4.4 units on a scale | Standard Deviation 0.66 |