NCT06592521

OPTI-FREE Family STUDY

OPTI-FREE Family (OPTI-FREE EXPRESS™, OPTI-FREE PureMoist™, OPTI-FREE REPLENISH™) PMCF STUDY

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Contact Lens Care

Interventions

Type	Name	Description
DEVICE	OPTI-FREE EXPRESS MPDS and Alcon contact lens case	Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct.
DEVICE	OPTI-FREE PureMoist MPDS and Alcon contact lens case	Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct.
DEVICE	OPTI-FREE REPLENISH MPDS and Alcon contact lens case	Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct.
DEVICE	Habitual contact lenses	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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-09-19
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study