OPTI-FREE Family STUDY

NCT06592521 | Withdrawn FDA Device

• 1 other identifier: LCO115-P002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contact Lens Care

Keywords

Contact Lens Solution

Outcome Measures

Primary Outcomes (5)

• Front surface deposits at 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.

  Day 90

• Back surface deposits at 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.

  Day 90

• Incidence of corneal infiltrative events

  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.

  Up to Day 90

• Incidence of microbial keratitis

  Microbial keratitis is a sight-threatening infection of the cornea. Incidences of microbial keratitis will be detected by the investigator during an eye exam.

  Up to Day 90

• Incidence of solution induced corneal staining (SICS)

  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.

  Up to Day 90

Study Arms (3)

OFE MPDS

EXPERIMENTAL

OPTI-FREE EXPRESS MPDS and Alcon contact lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.

Device: OPTI-FREE EXPRESS MPDS and Alcon contact lens case; Device: Habitual contact lenses

OFPM MPDS

EXPERIMENTAL

OPTI-FREE PureMoist MPDS and Alcon contact lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.

Device: OPTI-FREE PureMoist MPDS and Alcon contact lens case; Device: Habitual contact lenses

OFR MPDS

EXPERIMENTAL

OPTI-FREE REPLENISH MPDS and Alcon contact lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.

Device: OPTI-FREE REPLENISH MPDS and Alcon contact lens case; Device: Habitual contact lenses

Interventions

OPTI-FREE EXPRESS MPDS and Alcon contact lens case DEVICE

Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct.

Also known as: OFE

OFE MPDS

OPTI-FREE PureMoist MPDS and Alcon contact lens case DEVICE

Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct.

Also known as: OFPM

OFPM MPDS

OPTI-FREE REPLENISH MPDS and Alcon contact lens case DEVICE

Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct.

Also known as: OFR

OFR MPDS

Habitual contact lenses DEVICE

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.

OFE MPDS; OFPM MPDS; OFR MPDS

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)