AOSEPT Products 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, Ocular 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

Do I need to stop my current medications for the trial?

The trial requires that you do not use any systemic or eye medications that would interfere with wearing contact lenses. If you are using any eye drops or medications that affect your eyes, you may need to stop them to participate.

What data supports the effectiveness of the treatment AOSEPT Plus for contact lens hygiene?

Research shows that AOSEPT Plus is effective in reducing corneal staining and inflammatory responses compared to other lens care systems, indicating its effectiveness in maintaining eye health for contact lens users. ^{1 2 3 4 5}

Is AOSEPT safe for contact lens hygiene?

AOSEPT is generally safe for contact lens hygiene, but some users have reported stinging upon insertion. Studies show that AOSEPT may cause less corneal staining and inflammatory response compared to other solutions, although differences in eye reactions like redness and swelling have been noted over time. ^{2 3 4 6 7}

How does AOSEPT Plus differ from other contact lens cleaning treatments?

AOSEPT Plus is unique because it uses a hydrogen peroxide-based system for disinfecting contact lenses, which is effective against bacteria, yeast, mold, and resilient Acanthamoeba species. Unlike some other solutions, it requires a neutralization step to convert the hydrogen peroxide into a harmless saline solution, reducing the risk of irritation. ^{2 4 6 8 9}

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 2 commercially available contact lens cleaning and disinfecting systems in a pediatric population.

Research Team

Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

This clinical trial is for children who use contact lenses and need a cleaning and disinfecting system. The specific eligibility criteria are not provided, but typically participants must be in good general health with no eye conditions that would interfere with the study.

Inclusion Criteria

I can attend all required study visits.

Other protocol-specified inclusion criteria may apply

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

Exclusion Criteria

Any known sensitivity to any ingredients in the study products

Other protocol-specified exclusion criteria may apply

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 AOSEPT Plus or AOSEPT Plus with HydraGlyde 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

• AOSEPT Plus

Trial Overview The trial is testing two different commercially available contact lens solutions: AOSEPT Plus with AOCup lens case, and AOSEPT Plus with HydraGlyde and AOCup lens case. It aims to evaluate their long-term safety and effectiveness in kids.

Participant Groups

Group I: AOSEPT Plus with HydraGlyde (CCP) Experimental Treatment 2 Interventions

AOSEPT Plus with HydraGlyde and AOCup 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: AOSEPT Plus (CC) Experimental Treatment 2 Interventions

AOSEPT Plus and AOCup 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. England pubmed.ncbi.nlm.nih.gov

The efficacy of povidone-iodine, hydrogen peroxide and a chemical multipurpose contact lens care system against Pseudomonas aeruginosa on various lens case surfaces. [2021]

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

Ocular response to lens care systems in adolescent soft contact lens wearers. [2019]

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

Combined effect of comfort and adverse events on contact lens performance. [2019]

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

The comfort factor: assessing patient satisfaction with Opti-Free vs other contact lens cleaning products. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Effects of multipurpose solutions on the adhesion of Acanthamoeba to rigid gas permeable contact lenses. [2016]

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

Exploring the sting. [2015]

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

Contact lens-related adverse events and the silicone hydrogel lenses and daily wear care system used. [2022]

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

Hydrogen Peroxide Disinfecting Solution for Gas Permeable Contact Lenses: A Review of the Antimicrobial Efficacy, Compatibility, and Safety Performance of a One-Step Lens Care System. [2021]

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

Determination of protein deposits on RGP lenses by X-ray photoelectron spectroscopy. [2017]