Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clear Care Plus, then PeroxiClear | Other | Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles. |
|
| PeroxiClear, then Clear Care Plus | Other | PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clear Care Plus contact lens solution | Device | 3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 30, each product |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 30, each product |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, Vision Care, Global Medical Affairs | Alcon Research | Study Director |
Not provided
All randomized participants (132). One enrolled participant discontinued prior to randomization.
Participants were recruited from ten investigational centers located in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Clear Care Plus, Then PeroxiClear | Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles. |
| FG001 | PeroxiClear, Then Clear Care Plus | PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| ||||||||||||||||||||||||
| Period 2 |
|
Safety analysis set, defined as all participants randomized and treated. Two participants inadvertently used the incorrect product during the second period, and they are defined according to the treatment received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Clear Care Plus, Then PeroxiClear | Clear Care Plus was used in Period 1, then PeroxiClear in Period 2. |
| BG001 | PeroxiClear, Then Clear Care Plus | PeroxiClear was used in Period 1, then Clear Care Plus in Period 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intention to treat participants with non-missing observations | Posted | Mean | Standard Deviation | parts per million (ppm) | Day 30, each product | Lens Cases | Participants |
|
Adverse events (AEs) were collected for the duration of the study from the signing of informed consent (up to 60 [+10] days).
AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs, whether or not related to the medical device, obtained through solicited and spontaneous comments from all exposed participants and reported based on the treatment received. Ocular AEs are presented for both eyes combined.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PeroxiClear | While using PeroxiClear |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs Franchise Head, Vision Care | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PeroxiClear contact lens solution | Device | 3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses |
|
|
| Silicone hydrogel contact lenses | Device | 2-week/monthly replacement contact lenses per participant's habitual brand |
|
| NOT COMPLETED |
|
|
| BG002 | Clear Care Plus, Then Clear Care Plus | Clear Care Plus was used in Period 1 and in Period 2. |
| BG003 | PeroxiClear, Then PeroxiClear | PeroxiClear was used in Period 1 and in Period 2. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Clear Care Plus Lens Cases
|
|
| 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). | Intention to treat participants with non-missing observations | Posted | Mean | Standard Deviation | milliosmoles/kg (mOsm/kg) | Day 30, each product | Lens Cases | Participants |
|
|
|
| 0 |
| 130 |
| 0 |
| 130 |
| EG001 | Clear Care Plus | While using Clear Care Plus | 0 | 130 | 0 | 130 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.