Cleaning Solutions for Contact Lens Hygiene

Overseen By Alcon Call Center

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Must not be taking: Systemic medications

Disqualifiers: Ocular disease, Pathological dry eye, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you use any eye medications or drops that you need to apply during the study, you might not be eligible to participate.

What data supports the effectiveness of the treatment OPTI-FREE EXPRESS MPDS, OPTI-FREE PureMoist MPDS, OPTI-FREE REPLENISH MPDS for contact lens hygiene?

Research shows that OPTI-FREE RepleniSH MPDS improves comfort for contact lens wearers compared to other solutions, and OPTI-FREE Express MPDS has strong antimicrobial properties, helping to prevent infections by killing germs on contact lenses. ^{1 2 3 4 5}

Is the contact lens cleaning solution safe for humans?

The contact lens cleaning solutions, including OPTI-FREE EXPRESS MPDS, have been evaluated for safety in humans. Studies have shown that these solutions are designed to have low toxicity and allergenicity (low chance of causing allergic reactions) to eye tissues, making them generally safe for use. ^{1 2 3 4 5}

How is the OPTI-FREE MPDS treatment for contact lens hygiene different from other treatments?

The OPTI-FREE MPDS treatments, including EXPRESS, PureMoist, and REPLENISH, are unique because they contain antimicrobial agents like polyquaternium-1 and myristamidopropyl dimethylamine, which provide broad-spectrum antimicrobial activity, enhancing comfort and safety for contact lens wearers. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Research Team

Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

This clinical trial is for children and teenagers who use contact lenses. They must be willing to follow the study's procedures, including using specific lens cleaning solutions provided by the trial. The exact age range and other specific health requirements are not listed here.

Inclusion Criteria

I can attend all required study visits.

Successful wear of daily wear, reusable, soft contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day

Subject and parent/legally authorized representative able to understand and sign an IRB approved informed consent/assent form

Exclusion Criteria

Any known sensitivity to any ingredients in the study products

I do not have any eye conditions that prevent me from wearing contact lenses.

I am not on any medication that prevents me from wearing contact lenses.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use OPTI-FREE contact lens solutions with habitual contact lenses for 90 days

12 weeks

3 visits (2 telephone, 1 in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• OPTI-FREE EXPRESS MPDS
• OPTI-FREE PureMoist MPDS
• OPTI-FREE REPLENISH MPDS

Trial Overview The study tests three different OPTI-FREE products (EXPRESS, PureMoist, REPLENISH) used for cleaning and disinfecting contact lenses. Participants will use their usual contacts but switch between these solutions to see how they perform over time.

Participant Groups

Group I: OFR MPDS Experimental Treatment 2 Interventions

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 II: OFPM MPDS Experimental Treatment 2 Interventions

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 III: OFE MPDS Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

A multicenter investigation of OPTI-FREE RepleniSH multi-purpose disinfecting solution impact on soft contact lens patient comfort. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Broad spectrum antimicrobial activity of a new multi-purpose disinfecting solution. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a new multi-purpose disinfecting solution in symptomatic contact lens wearers. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Multi-site clinical assessment of Complete Revitalens MPDS in 2981 contact lens wearers across Europe and USA. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Daily Contact Lens Cleaning on Ocular Adverse Events during Extended Wear. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Ocular tolerance of a new multipurpose solution specifically formulated for daily wear of silicone hydrogel contact lenses. [2011]