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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety and effectiveness of three contact lens cleaning solutions for kids and teens. Participants will use one of the OPTI-FREE brand solutions (OPTI-FREE EXPRESS MPDS, OPTI-FREE PureMoist MPDS, or OPTI-FREE REPLENISH MPDS) with their usual contact lenses to evaluate the solutions' performance over a 90-day period. Kids who have worn daily soft contact lenses for at least 8 hours a day, 5 days a week, over the past three months may be suitable for this study. The trial takes place in Canada and the U.S. As an unphased trial, this study allows participants to contribute to valuable research on contact lens care for young people.

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

Research shows that the three OPTI-FREE contact lens solutions—Express, PureMoist, and Replenish—are generally safe and well-tolerated.

The OPTI-FREE Express solution effectively cleans and disinfects contact lenses, reducing the risk of eye infections by killing bacteria. OPTI-FREE PureMoist is highly effective against Acanthamoeba, a microorganism that can cause serious eye problems. It cleans and disinfects 99.9% of bacteria, providing comfort and safety for lens users.

The OPTI-FREE Replenish solution features a disinfectant system that reduces harmful microorganisms, helping to prevent eye infections. Users report that their lenses feel clean and moist, and many find it gentle on their eyes.

These solutions are available in stores, indicating their safety. Many people have used them with positive results and few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new contact lens cleaning solutions because they aim to elevate the standard of lens hygiene with unique formulations. Unlike many existing solutions, OPTI-FREE EXPRESS, PureMoist, and REPLENISH MPDS are designed to enhance moisture retention, providing all-day comfort for lens wearers. The PureMoist variant, in particular, includes HydraGlyde Moisture Matrix, which creates a cushion of moisture that lasts throughout the day. These innovative features could lead to improved comfort and protection against eye infections, setting them apart from traditional cleaning solutions.

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

This trial will compare different OPTI-FREE cleaning solutions for contact lens hygiene. Research has shown that OPTI-FREE cleaning solutions effectively keep contact lenses clean and comfortable. Participants may receive OPTI-FREE EXPRESS, which studies have found can kill 99.9% of bacteria, helping to protect the eyes. Another group will use OPTI-FREE PureMoist, with 88.3% of users reporting all-day comfort and surveys indicating significant improvements in comfort and moisture. A third group will use OPTI-FREE REPLENISH, with 91% of users stating their lenses felt clean and gentle on their eyes. These solutions are well-known for maintaining moisture, cleanliness, and comfort throughout the day. ^{6 7 8 9 10}

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 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

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

I can attend all required study visits.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2819769/

A multicenter investigation of OPTI-FREE® RepleniSH® ... Of these respondents, 91% rated their lenses as feeling clean, 91% found it to be gentle on the eyes, 84% felt their lenses were moist, 83% noted lasting ...

2. researchgate.net researchgate.net/publication/270132201_Results_from_a_global_survey_of_contact_lens-wearer_satisfaction_with_OPTI-FREER_PureMoistR_Multi-Purpose_Disinfecting_Solution

(PDF) Results from a global survey of contact lens-wearer ... (PDF) Results from a global survey of contact lens-wearer satisfaction with OPTI-FREE® PureMoist® Multi-Purpose Disinfecting Solution.

3. dovepress.com dovepress.com/article/download/15003

wearer satisfaction with OPTi-Free® PureMoist® Multi- ... Australia had the largest absolute increase (31 percentage points) in reports of all-day comfort after 2 weeks of. OPTI-FREE PureMoist MPDS use (58% versus 89%;.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06592521?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BInterventionSearch%5D(DIPIVEFRIN%20HYDROCHLORIDE)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)))&rank=2

Study Details | NCT06592521 | OPTI-FREE Family STUDY Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in ...

5. myalcon.com myalcon.com/car/contact-lenses/contact-lens-solutions/opti-free-express/

OPTI-FREE® Express® Contact Solution | Alcon Caribbean It cleans and disinfect 99.9% of bacteria. By using OPTI-FREE®, you make sure that your eye health is on safe hands. Recommended for: Monthly contact lens ...

6. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9ABTMO_SOLUTION_CONTACT_MULTI_PURP_4OZ.pdf

Safety Data Sheet Recommended use and restriction on use · Recommended use: Lens Care Product · Restrictions on use: Contact manufacturer.

7. myalcon.com myalcon.com/professional/contact-lenses/contact-lens-solutions/opti-free/

OPTI-FREE® Contact Solution Technology | Alcon Professional Removes debris to keep contact lenses clean and clear7. Product bottle and ... See product instructions for complete wear, care and safety information.

8. pdf.hres.ca pdf.hres.ca/dpd_pm/00023838.PDF

OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution Extended-wear lenses should be removed regularly for cleaning and disinfection or for disposal and replacement on the schedule prescribed by eye ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf2/k021143.pdf

AUG 0 8 2002 - accessdata.fda.gov It was concluded that the OPTI-FREE Express FID 90746 Investigational Regimen provides effective disinfection of contact lenses based on IS0 ...

10. rpdinc.com rpdinc.com/opti-free-pure-moist-contact-lens-solution-4-ounce-8888.html

Opti-Free Pure Moist Contact Lens Solution, 4 Ounce The Opti-free Express Solution cleans, disinfects and removes protein daily. The no-rub solution kills bacteria that can cause eye infections.