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Disinfecting System

AOSEPT Products for Contact Lens Hygiene

N/A

Waitlist Available

Research Sponsored by Alcon Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Any ocular disease or condition that would contraindicate contact lens wear

Use of systemic or ocular medication that would contraindicate contact lens wear

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 90

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to assess the safety and effectiveness of two contact lens cleaning products in children over a long period of time after they have been released to the market.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the exact side effects are not listed, potential ones may include eye irritation, discomfort while wearing lenses, allergic reactions or infections due to improper cleaning or individual sensitivity to solution ingredients.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have any eye conditions that prevent me from wearing contact lenses.

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

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I regularly use eye drops or medication for my eyes that I would need to continue during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Back surface deposits at Day 90

Front surface deposits at Day 90

Incidence of corneal infiltrative events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: AOSEPT Plus with HydraGlyde (CCP)Experimental Treatment2 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 Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Habitual contact lenses

2014

N/A

~710

0 / 3Eligibility criteria met