Status:
WITHDRAWN
AOSEPT (CLEAR CARE) PLUS Study
Lead Sponsor:
Alcon Research
Conditions:
Contact Lens Care
Eligibility:
All Genders
7-17 years
Phase:
NA
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 pedi...
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 ±...
Eligibility Criteria
Inclusion
- Key
- 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
- 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 exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06588400
Start Date
October 1 2025
End Date
January 1 2026
Last Update
September 16 2025
Active Locations (1)
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1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134