OPTI-FREE Family STUDY

Launched by ALCON RESEARCH · Sep 10, 2024

Keywords

ClinConnect Summary

The OPTI-FREE Family STUDY is a clinical trial designed to look at the long-term safety and effectiveness of three different cleaning and disinfecting solutions for contact lenses, specifically in children and teenagers. This study will take place in Canada and the United States and aims to ensure that these products are safe for young users who wear contact lenses regularly.

To participate in this study, children aged 8 to 17 who have been wearing soft contact lenses (like hydrogel or silicone hydrogel) for at least three months are eligible, as long as they can attend all study visits and their parent or guardian can provide consent. However, some individuals may not be able to join if they have certain eye conditions or are using medications that could affect contact lens wear. Participants will be monitored over time to help researchers understand how well the lens cleaning solutions work and if they are safe for young eyes.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Subject and parent/legally authorized representative able to understand and sign an IRB 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) 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.