Myopia, Hyperopia, Contact Lens Comfort
Conditions
Keywords
multi-purpose solution, silicone hydrogel, contact lenses, comfort, Opti-Free, RevitaLens
Brief summary
The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.
Detailed description
In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist MPDS or RevitaLens MPDS in Period 1 for use with their habitual contact lenses, after which they switched to the alternate solution in Period 2. Each period was 30 days in length. A 2-day washout period during which participants refrained from using a multi-purpose contact lens solution preceded Period 1 and Period 2.
Interventions
DEVICERevitaLens MPDS
DEVICEHabitual Contact Lenses
Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least 1 month prior to Visit 1; * Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on 2 days during the study; * Must have habitually used a biguanide preserved multi-purpose solution (other than RevitaLens) for at least 30 days prior to Visit 1; * Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1; * Have access, capability and willingness to review and answer text messages; * Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment; * Willing to follow the study procedures and visit schedule; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Need to wear lenses on an extended wear (i.e overnight) basis during the study; * Known sensitivity or intolerance to biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products; * Monocular (only one eye with functional vision) or fit with only one lens; * Wearing toric or multifocal contact lenses or fit with monovision; * Use of additional lens care products other than a biguanide preserved multi-purpose solution such as daily or enzyme cleaners within the 1 week prior to Visit 1; * Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1; * Abnormal ocular condition observed during the Visit 1 slit-lamp examination; * Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1; * Ocular surgery within the 12 months prior to Visit 1; * Participation in any other clinical trial within 30 days of enrollment; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Lens Wear Comfort | Day 30 | Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, When I use this solution, I can comfortably wear my lenses, with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree. |
Participant flow
Recruitment details
Participants were recruited from 5 study centers located in the US, 2 study centers located in the UK, and 3 study centers located in Germany.
Pre-assignment details
Of the 196 enrolled, 4 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who were exposed to a study regimen (test or control) (192).
Participants by arm
| Arm | Count |
|---|---|
| PureMoist / RevitaLens Opti-Free® PureMoist® MPDS and RevitaLens MPDS used during Period 1 and Period 2 in randomized order in crossover assignment. | 192 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 30 Days | Adverse Event | 0 | 2 |
Baseline characteristics
| Characteristic | PureMoist / RevitaLens |
|---|---|
| Age, Continuous | 32.0 years STANDARD_DEVIATION 11.42 |
| Sex: Female, Male Female | 142 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 190 | 0 / 192 |
| serious Total, serious adverse events | 0 / 190 | 0 / 192 |
Outcome results
Primary
Subjective Lens Wear Comfort
Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, When I use this solution, I can comfortably wear my lenses, with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.
Time frame: Day 30
Population: This analysis population includes all participants who were exposed to study regimen (test and control) and completed both study periods, excluding major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PureMoist | Subjective Lens Wear Comfort | 4.3 units on a scale | Standard Deviation 0.89 |
| RevitaLens | Subjective Lens Wear Comfort | 4.3 units on a scale | Standard Deviation 0.72 |