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The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 3 commercially available contact lens cleaning and disinfecting solutions in a pediatric population. This study will be conducted in Canada and the US.
Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFE MPDS | Experimental | OPTI-FREE EXPRESS MPDS and Alcon contact lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation. |
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| OFPM MPDS | Experimental | OPTI-FREE PureMoist MPDS and Alcon contact lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation. |
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| OFR MPDS | Experimental | OPTI-FREE REPLENISH MPDS and Alcon contact lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTI-FREE EXPRESS MPDS and Alcon contact lens case | Device | Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct. |
| Measure | Description | Time Frame |
|---|---|---|
| Front surface deposits at Day 90 | Protein and lipid deposits on the front surface of the contact lens will be assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits will be graded on a 5-point scale, with 0 being absent and 4 being severe. | Day 90 |
| Back surface deposits at Day 90 | Protein and lipid deposits on the back surface of the contact lens will be assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits will be graded on a 5-point scale, with 0 being absent and 4 being severe. | Day 90 |
| Incidence of corneal infiltrative events | A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea. Corneal infiltrative events will be detected by the investigator during an eye exam. | Up to Day 90 |
| Incidence of microbial keratitis | Microbial keratitis is a sight-threatening infection of the cornea. Incidences of microbial keratitis will be detected by the investigator during an eye exam. | Up to Day 90 |
| Incidence of solution induced corneal staining (SICS) | Corneal staining determined by the investigator to be solution-related will be graded by type (pattern of staining) and area (how much) in each of the 5 corneal regions: central, superior, nasal, inferior, temporal. | Up to Day 90 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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| OPTI-FREE PureMoist MPDS and Alcon contact lens case | Device | Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct. |
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| OPTI-FREE REPLENISH MPDS and Alcon contact lens case | Device | Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct. |
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| Habitual contact lenses | Device | Daily wear, reusable, soft (including hydrogel and silicone hydrogel) contact lenses according to subject's habitual prescription worn in both eyes and removed prior to sleep for cleaning and disinfection with the study product provided. |
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