Contact Lens Care
Conditions
Keywords
Contact Lens Solution
Brief summary
The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 2 commercially available contact lens cleaning and disinfecting systems in a pediatric population.
Detailed description
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.
Interventions
DEVICEAOSEPT Plus and AOCup lens case
Commercially available cleaning, disinfecting, and storage system consisting of a hydrogen-peroxide based solution (AOSEPT Plus) and a lens case (AOCup) with a neutralizer disc. The solution and lens case must be used together.
DEVICEAOSEPT Plus with HydraGlyde and AOCup lens case
Commercially available cleaning, disinfecting, and storage system consisting of a hydrogen-peroxide based solution (AOSEPT Plus with HydraGlyde) and a lens case (AOCup) with a neutralizer disc. The solution and lens case must be used together.
DEVICEHabitual contact lenses
Daily wear, reusable, soft (including hydrogel and silicone hydrogel) or rigid gas permeable (RGP) 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.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subject and parent/legally authorized representative able to understand and sign an Institution Review Board approved informed consent/assent form. * Subject willing to follow and be able to attend all scheduled study visits as required per protocol. * Successful wear of daily wear, reusable, soft (including hydrogel and silicone hydrogel) or rigid gas permeable (RGP) contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Any ocular disease or condition that would contraindicate contact lens wear. * Use of systemic or ocular medication that would contraindicate contact lens wear. * Any known sensitivity to any ingredients in the study products. * Current or history of pathological dry eye in either eye that would in the opinion of the Investigator preclude contact lens wear. * Any use of habitual/prescribed topical ocular medication or artificial tear or rewetting drop (habitual) that would require instillation during the study. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Front surface deposits at Day 90 | 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. |
| Back surface deposits at Day 90 | 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. |
| Incidence of corneal infiltrative events | Up to Day 90 | 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. |
| Incidence of microbial keratitis | Up to Day 90 | Microbial keratitis is a sight-threatening infection of the cornea. Incidences of microbial keratitis will be detected by the investigator during an eye exam. |
| Incidence of solution induced corneal staining (SICS) | Up to Day 90 | 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. |
Countries
United States
Outcome results
None listed