Refractive Error
Conditions
Keywords
Contact lens solution
Brief summary
The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.
Detailed description
Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.
Interventions
DEVICEClear Care Plus contact lens solution
3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses
DEVICEPeroxiClear contact lens solution
3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses
2-week/monthly replacement contact lenses per participant's habitual brand
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
* Sign informed consent form; * Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months); * Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits; * Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Current hydrogen peroxide-based solution user; * Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment; * Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day; * Use of systemic or ocular medications for which contact lens wear could be contraindicated; * Monocular (only 1 eye with functional vision) or fit with only 1 lens; * History of herpetic keratitis, ocular surgery, or irregular cornea; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Residual Peroxide at Day 30 | Day 30, each product | The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Osmolality in Lens Cases at Day 30 | Day 30, each product | The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear). |
Participant flow
Recruitment details
Participants were recruited from ten investigational centers located in the United States.
Pre-assignment details
All randomized participants (132). One enrolled participant discontinued prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Clear Care Plus, Then PeroxiClear Clear Care Plus was used in Period 1, then PeroxiClear in Period 2. | 65 |
| PeroxiClear, Then Clear Care Plus PeroxiClear was used in Period 1, then Clear Care Plus in Period 2. | 65 |
| Clear Care Plus, Then Clear Care Plus Clear Care Plus was used in Period 1 and in Period 2. | 1 |
| PeroxiClear, Then PeroxiClear PeroxiClear was used in Period 1 and in Period 2. | 1 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 0 |
| Period 1 | Reason Not Specified | 0 | 1 |
| Period 2 | Protocol Deviation | 1 | 0 |
Baseline characteristics
| Characteristic | Clear Care Plus, Then PeroxiClear | PeroxiClear, Then Clear Care Plus | Clear Care Plus, Then Clear Care Plus | PeroxiClear, Then PeroxiClear | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 11.2 | 35.7 years STANDARD_DEVIATION 11.8 | 42.0 years | 38.0 years | 36.7 years STANDARD_DEVIATION 11.4 |
| Age, Customized 18-64 years | 65 participants | 64 participants | 1 participants | 1 participants | 131 participants |
| Age, Customized ≥65 years | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 52 Participants | 49 Participants | 1 Participants | 1 Participants | 103 Participants |
| Sex: Female, Male Male | 13 Participants | 16 Participants | 0 Participants | 0 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 130 | 0 / 130 |
| serious Total, serious adverse events | 0 / 130 | 0 / 130 |
Outcome results
Primary
Mean Residual Peroxide at Day 30
The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
Time frame: Day 30, each product
Population: Intention to treat participants with non-missing observations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PeroxiClear | Mean Residual Peroxide at Day 30 | 229.7 parts per million (ppm) | Standard Deviation 280.13 |
| Clear Care Plus | Mean Residual Peroxide at Day 30 | 26.2 parts per million (ppm) | Standard Deviation 41.17 |
Secondary
Mean Osmolality in Lens Cases at Day 30
The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
Time frame: Day 30, each product
Population: Intention to treat participants with non-missing observations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PeroxiClear | Mean Osmolality in Lens Cases at Day 30 | 345.1 milliosmoles/kg (mOsm/kg) | Standard Deviation 11.76 |
| Clear Care Plus | Mean Osmolality in Lens Cases at Day 30 | 299.2 milliosmoles/kg (mOsm/kg) | Standard Deviation 7.63 |