Normal Contact Lens Wearers
Conditions
Brief summary
Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.
Detailed description
This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.
Interventions
DEVICEMulti-purpose disinfecting solution
For the cleaning, rinsing, and storage of soft contact lenses.
DEVICEClear Care
Peroxide-based regimen for cleaning and disinfecting soft contact lenses.
DEVICEOpti-Free RepleniSH
Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses.
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Is at least 17 years of age and has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Has had an ocular examination in the last two years; * Is a current soft lens wearer using either two-week or monthly replacement lenses; * Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction (either spectacles or contact lenses); * Has normal binocular vision (no strabismus, no amblyopia); * Has clear corneas and no active ocular disease; * Has a distance contact lens prescription between +8.00 diopters (D) to -12.00 D and a successful fit with the study lenses; * Has astigmatism less than or equal to -1.00 D; * Agrees to wear the study lenses on a daily wear basis.
Exclusion criteria
* Has any active ocular disease; * Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable; * Has undergone corneal refractive surgery; * Has a systemic condition that may affect a study outcome variable; * Is using any systemic or topical medications that may affect ocular health; * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; * Is pregnant or lactating; * Is participating in any other clinical or research study that may affect a study outcome variable; * Currently wears daily disposable lenses or extended wear lenses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining | 4 weeks | Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Lens Wearing Comfort | 4 weeks | This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale. |
| Dryness | 4 weeks | This will be assessed by the tear break-up time on the lens surface, measured in seconds. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inconvenience | 1 |
| Overall Study | Relocation | 5 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age, Continuous | 28.1 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment Canada | 42 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Corneal Staining
Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.
Time frame: 4 weeks
Population: Only subjects that completed all three arms were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AMO Investigational MPS | Corneal Staining | 184 units on a scale | Standard Deviation 381.6 |
| Clear Care | Corneal Staining | 46.6 units on a scale | Standard Deviation 91.3 |
| OptiFree RepleniSH MPS | Corneal Staining | 77.8 units on a scale | Standard Deviation 131.7 |
Secondary
Dryness
This will be assessed by the tear break-up time on the lens surface, measured in seconds.
Time frame: 4 weeks
Secondary
Subjective Lens Wearing Comfort
This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.
Time frame: 4 weeks