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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the long-term safety and effectiveness of two contact lens cleaning systems, AOSEPT Plus and AOSEPT Plus with HydraGlyde, for children who wear contact lenses. Participants will use these products with their usual contact lenses for 90 days. It suits children who have worn daily reusable soft or rigid gas permeable (RGP) contact lenses for at least 8 hours a day, five days a week, over the past three months. As an unphased trial, this study offers a unique opportunity for participants to contribute to research that could enhance contact lens care for children.

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 prior data suggests that these contact lens cleaning systems are safe for children?

Research has shown that AOSEPT Plus and AOSEPT Plus with HydraGlyde are generally safe for contact lens users. These preservative-free solutions clean and disinfect lenses effectively. However, careful use is crucial. They contain hydrogen peroxide, which can irritate or harm eyes if misused. Improper handling or inadequate rinsing of lenses has led to reports of pain, blurry vision, and redness. Despite these reports, both products are approved for use with contact lenses, indicating safety when used as directed. Always follow the product instructions to minimize risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because AOSEPT Plus and AOSEPT Plus with HydraGlyde offer a unique approach to contact lens hygiene. Unlike traditional multipurpose solutions, which clean and disinfect in one step, AOSEPT uses a hydrogen peroxide-based system that provides a deep clean by breaking down into water and oxygen, leaving no preservatives that can irritate the eyes. The addition of HydraGlyde in one of the treatments offers enhanced moisture retention for the lenses, potentially improving comfort for wearers. This combination of thorough cleaning and added moisture sets these treatments apart from standard lens care options.

What evidence suggests that this trial's treatments could be effective for contact lens hygiene?

Research has shown that AOSEPT Plus, one of the treatments in this trial, effectively cleans and disinfects contact lenses using hydrogen peroxide. It helps lenses remain comfortable longer by enhancing their ability to stay wet over time. AOSEPT Plus has been proven to deactivate harmful organisms like Acanthamoeba, which can cause problems if not properly controlled.

AOSEPT Plus with HydraGlyde, another treatment option in this trial, provides the same cleaning benefits while also helping lenses retain moisture. This means lenses can feel fresher and more comfortable throughout the day. Both solutions are designed to thoroughly clean and kill bacteria without added preservatives. ^{5 6 7 8 9}

Who Is on the Research Team?

Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7813461/

Hydrogen Peroxide Disinfecting Solution for Gas ... CLEAR CARE (also known as AOSEPT PLUS) is a 3% hydrogen peroxide cleaning and disinfecting solution for contact lenses (Alcon Laboratories, LLC ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01594294

Study Details | NCT01594294 | An Evaluation of Marketed ... The purpose of this study was to assess and compare the effect of the repeated usage of 2 different care systems (one hydrogen peroxide ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1367048415300096

Effect of lens care system on silicone hydrogel contact ... A significant improvement in contact lens wettability was recorded compared with the habitual care system at the three-month follow-up visit.

4. myalcon.com myalcon.com/au/professional/contact-lenses/contact-lens-solutions/

Discover Alcon's Contact Lens Solutions - MyAlcon AOSEPT PLUS® WITH HYDRAGLYDE®. AOSEPT PLUS® with HydraGlyde™ Solution cleans and disinfects your contact lenses with the bubbling power of hydrogen peroxide.

5. seronjihou.com seronjihou.com/wp-content/uploads/2021/03/282220.pdf

Effectiveness of AOSept Plus and Biotrue® Contact Lens ... AOSept Plus was found to be effective in inactivating the cysts of all Acanthamoeba isolates for all the soaking times tested.

6. menards.com menards.com/main/items/media/ALCON001/SDS/ClearCarePluswithHydraglydeSDS.PDF

SAFETY DATA SHEET This product causes skin irritation and serious eye damage. It is classified as Skin Corrosion/Irritation Category 2 and Serious Eye Damage/Eye ...

7. myalcon.com myalcon.com/dk/professional/contact-lenses/contact-lens-solutions/aosept-plus-hydraglyde/

AOSEPT™ PLUS with HydraGlyde™ | Alcon Denmark AOSEPT™ PLUS with HydraGlyde™ provides long-lasting moisture, a feeling of clean lenses, deep cleans, kills bacteria, and is preservative-free.

8. myalcon.com myalcon.com/au/contact-lenses/contact-lens-solutions/aosept-plus/

AOSEPT™ PLUS Peroxide Contact Lens Solution - MyAlcon Preservative-free hydrogen peroxide solution. A gold standard in contact lens solutions that provides removal of protein deposits from the lens surface.

9. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6749708&pc=LPN

ALCON LABORATORIES, INC. AOSEPT PLUS/CLEAR CARE ... On (b)(6) 2017, patient experienced strong pain, blurry vision, photophobia and excessive tearing, along with red and swollen eyelids in one of the eyes.The ...