OPTI-FREE Family STUDY

NCT ID: NCT06592521

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

OFE MPDS

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.

Group Type: EXPERIMENTAL

OPTI-FREE EXPRESS MPDS and Alcon contact lens case

Intervention Type: DEVICE

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

Habitual contact lenses

Intervention Type: 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.

OFPM MPDS

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.

Group Type: EXPERIMENTAL

OPTI-FREE PureMoist MPDS and Alcon contact lens case

Intervention Type: DEVICE

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

Habitual contact lenses

Intervention Type: 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.

OFR MPDS

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.

Group Type: EXPERIMENTAL

OPTI-FREE REPLENISH MPDS and Alcon contact lens case

Intervention Type: DEVICE

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

Habitual contact lenses

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

OFE; OFPM; OFR

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

LCO115-P002

Identifier Type: -

Identifier Source: org_study_id