AOSEPT (CLEAR CARE) PLUS Study

Launched by ALCON RESEARCH · Sep 6, 2024

Keywords

ClinConnect Summary

The AOSEPT (CLEAR CARE) PLUS Study is a clinical trial aimed at understanding how safe and effective two types of contact lens cleaning and disinfecting systems are for children and teenagers who wear contact lenses. Although this study is not yet recruiting participants, it will focus on young people aged between 6 and 18 years who have been wearing contact lenses regularly for at least three months.

To participate, children must be able to understand and agree to the study rules, and their parents or guardians must also provide consent. Additionally, they should not have any eye problems or use certain medications that would make wearing contact lenses unsafe. Participants will attend scheduled visits where they will be monitored for their use of the contact lens cleaning systems. This study is important because it will help ensure that the products used for cleaning contact lenses are safe and effective for younger users.

Gender

ALL

Eligibility 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 exclusion criteria may apply.