Myopia
Conditions
Brief summary
Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).
Detailed description
To determine if patients are unreactive to the lens care solution / Biofinity combination. It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), & V3 (2 weeks).
Interventions
DEVICEBioclean MPS VII
PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
DEVICEAosept Clearcare
Hydrogen Peroxide Disinfecting and Cleaning system
DEVICEcomfilcon A
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is over 18 years of age (inclusive) * Has had a self-reported visual exam in the last two years * Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive) * Has less than 1.00 D spectacle cylinder in each eye * Is correctable to a visual acuity of 20/20 or better in both eyes * Has clear corneas and no active ocular disease * Has read, understood and signed the informed consent letter * Is willing to comply with the wear schedule (at least 40hrs per week) * Is willing to comply with the visit schedule
Exclusion criteria
* Has never worn contact lenses before * Currently wears rigid gas permeable contact lens * Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; \> 8 hours per day) * Has a CL prescription outside the range of -0.25D to -12.00D * Has a spectacle cylinder greater than -0.75D of cylinder in either eye * Has best corrected spectacle distant vision worse than 20/20 in ether eye * Has any systemic disease affecting ocular health * Is using any systemic or topical medications that will affect ocular health * Has any ocular pathology or sever insufficiency of lacrimal secretion * Has persistent, clinically significant corneal or conjunctival staining * Has active neovascularization or any central corneal scars * Is aphakic * Is pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Health - Corneal Staining | 1 week | Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 1 week | Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent. |
| Dryness | 1 week | Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent. |
| Stinging and Burning Sensation | Baseline | Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Participants were randomized to the Bioclean MPS VII / comfilcon A combination or Aosept Clearcare / comfilcon A combination for one week, then cross over to the alternative combination. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Ocular Health - Corneal Staining
Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bioclean MPS VII / Comfilcon A Combination | Ocular Health - Corneal Staining | Trace | 21 Eyes |
| Bioclean MPS VII / Comfilcon A Combination | Ocular Health - Corneal Staining | Moderate | 0 Eyes |
| Bioclean MPS VII / Comfilcon A Combination | Ocular Health - Corneal Staining | Mild | 0 Eyes |
| Bioclean MPS VII / Comfilcon A Combination | Ocular Health - Corneal Staining | Severe | 0 Eyes |
| Bioclean MPS VII / Comfilcon A Combination | Ocular Health - Corneal Staining | Normal | 45 Eyes |
| Aosept Clearcare / Comfilcon A Combination | Ocular Health - Corneal Staining | Severe | 0 Eyes |
| Aosept Clearcare / Comfilcon A Combination | Ocular Health - Corneal Staining | Normal | 53 Eyes |
| Aosept Clearcare / Comfilcon A Combination | Ocular Health - Corneal Staining | Trace | 13 Eyes |
| Aosept Clearcare / Comfilcon A Combination | Ocular Health - Corneal Staining | Mild | 0 Eyes |
| Aosept Clearcare / Comfilcon A Combination | Ocular Health - Corneal Staining | Moderate | 0 Eyes |
Secondary
Comfort
Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bioclean MPS VII / Comfilcon A Combination | Comfort | After 4 hours of wear | 9.52 units on a scale | Standard Deviation 0.71 |
| Bioclean MPS VII / Comfilcon A Combination | Comfort | Before removal | 8.55 units on a scale | Standard Deviation 1.13 |
| Bioclean MPS VII / Comfilcon A Combination | Comfort | After 8 hours of wear | 8.99 units on a scale | Standard Deviation 1.03 |
| Bioclean MPS VII / Comfilcon A Combination | Comfort | All day comfort | 9.15 units on a scale | Standard Deviation 0.85 |
| Bioclean MPS VII / Comfilcon A Combination | Comfort | After insertion | 9.24 units on a scale | Standard Deviation 1.42 |
| Aosept Clearcare / Comfilcon A Combination | Comfort | All day comfort | 8.89 units on a scale | Standard Deviation 1.14 |
| Aosept Clearcare / Comfilcon A Combination | Comfort | After insertion | 9.30 units on a scale | Standard Deviation 1.54 |
| Aosept Clearcare / Comfilcon A Combination | Comfort | After 4 hours of wear | 9.44 units on a scale | Standard Deviation 1.05 |
| Aosept Clearcare / Comfilcon A Combination | Comfort | After 8 hours of wear | 9.10 units on a scale | Standard Deviation 1.16 |
| Aosept Clearcare / Comfilcon A Combination | Comfort | Before removal | 8.65 units on a scale | Standard Deviation 1.39 |
Secondary
Dryness
Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bioclean MPS VII / Comfilcon A Combination | Dryness | Before removal | 8.26 units on a scale | Standard Deviation 1.29 |
| Bioclean MPS VII / Comfilcon A Combination | Dryness | All day dryness | 8.92 units on a scale | Standard Deviation 1 |
| Bioclean MPS VII / Comfilcon A Combination | Dryness | After Insertion | 9.67 units on a scale | Standard Deviation 0.69 |
| Bioclean MPS VII / Comfilcon A Combination | Dryness | After 4 hours of wear | 9.27 units on a scale | Standard Deviation 0.87 |
| Bioclean MPS VII / Comfilcon A Combination | Dryness | After 8 hours of wear | 8.65 units on a scale | Standard Deviation 1.22 |
| Aosept Clearcare / Comfilcon A Combination | Dryness | After 8 hours of wear | 8.91 units on a scale | Standard Deviation 1.03 |
| Aosept Clearcare / Comfilcon A Combination | Dryness | After 4 hours of wear | 9.38 units on a scale | Standard Deviation 0.86 |
| Aosept Clearcare / Comfilcon A Combination | Dryness | All day dryness | 8.92 units on a scale | Standard Deviation 1 |
| Aosept Clearcare / Comfilcon A Combination | Dryness | Before removal | 8.33 units on a scale | Standard Deviation 1.35 |
| Aosept Clearcare / Comfilcon A Combination | Dryness | After Insertion | 9.77 units on a scale | Standard Deviation 0.65 |
Secondary
Stinging and Burning Sensation
Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bioclean MPS VII / Comfilcon A Combination | Stinging and Burning Sensation | Stinging Sensation | 9.42 units on a scale | Standard Deviation 0.93 |
| Bioclean MPS VII / Comfilcon A Combination | Stinging and Burning Sensation | Burning Sensation | 9.97 units on a scale | Standard Deviation 0.17 |
| Aosept Clearcare / Comfilcon A Combination | Stinging and Burning Sensation | Stinging Sensation | 9.50 units on a scale | Standard Deviation 0.93 |
| Aosept Clearcare / Comfilcon A Combination | Stinging and Burning Sensation | Burning Sensation | 9.91 units on a scale | Standard Deviation 0.38 |