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Outcome Measures

Primary Outcomes (5)

Front surface deposits at Day 90
Protein and lipid deposits on the front surface of the contact lens will be assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits will be graded on a 5-point scale, with 0 being absent and 4 being severe.
Day 90
Back surface deposits at Day 90
Protein and lipid deposits on the back surface of the contact lens will be assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits will be graded on a 5-point scale, with 0 being absent and 4 being severe.
Day 90
Incidence of corneal infiltrative events
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea. Corneal infiltrative events will be detected by the investigator during an eye exam.
Up to Day 90
Incidence of microbial keratitis
Microbial keratitis is a sight-threatening infection of the cornea. Incidences of microbial keratitis will be detected by the investigator during an eye exam.
Up to Day 90

Study Arms (2)

AOSEPT Plus (CC)

EXPERIMENTAL

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.

Device: AOSEPT Plus and AOCup lens caseDevice: Habitual contact lenses

AOSEPT Plus with HydraGlyde (CCP)

EXPERIMENTAL

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.

Device: AOSEPT Plus with HydraGlyde and AOCup lens caseDevice: Habitual contact lenses

Interventions

AOSEPT Plus and AOCup lens caseDevice

Commercially available cleaning, disinfecting, and storage system consisting of a hydrogen-peroxide based solution (AOSEPT Plus) and a lens case (AOCup) with a neutralizer disc. The solution and lens case must be used together.

Also known as: Clear Care (CC)

AOSEPT Plus (CC)

AOSEPT Plus with HydraGlyde and AOCup lens caseDevice

Commercially available cleaning, disinfecting, and storage system consisting of a hydrogen-peroxide based solution (AOSEPT Plus with HydraGlyde) and a lens case (AOCup) with a neutralizer disc. The solution and lens case must be used together.

Eligibility Criteria

Age7 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Subject and parent/legally authorized representative able to understand and sign an Institution Review Board approved informed consent/assent form.
Subject willing to follow and be able to attend all scheduled study visits as required per protocol.

Study Stopped

AOSEPT (CLEAR CARE) PLUS Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

AOSEPT Plus (CC)

AOSEPT Plus with HydraGlyde (CCP)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

AOSEPT Plus (CC)

AOSEPT Plus with HydraGlyde (CCP)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations