AOSEPT (CLEAR CARE) PLUS Study

September 10, 2025 updated by: Alcon Research

AOSEPT™ PLUS With HydraGlyde FID 120947A and AOCup Lens Case (CLEAR CARE PLUS) and AOSEPT™ PLUS FID 119056 and AOCup Lens Case (CLEAR CARE) Family PMCF Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.
  • Successful wear of daily wear, reusable, soft (including hydrogel and silicone hydrogel) or rigid gas permeable (RGP) contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any ocular disease or condition that would contraindicate contact lens wear.
  • Use of systemic or ocular medication that would contraindicate contact lens wear.
  • Any known sensitivity to any ingredients in the study products.
  • Current or history of pathological dry eye in either eye that would in the opinion of the Investigator preclude contact lens wear.
  • Any use of habitual/prescribed topical ocular medication or artificial tear or rewetting drop (habitual) that would require instillation during the study.
  • Other protocol-specified exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AOSEPT Plus (CC)
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 case
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.
Other Names:
  • Clear Care (CC)
Device: Habitual contact lenses
Daily wear, reusable, soft (including hydrogel and silicone hydrogel) or rigid gas permeable (RGP) contact lenses according to subject's habitual prescription worn in both eyes and removed prior to sleep for cleaning and disinfection with the study product provided.
Experimental: AOSEPT Plus with HydraGlyde (CCP)
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: Habitual contact lenses
Daily wear, reusable, soft (including hydrogel and silicone hydrogel) or rigid gas permeable (RGP) contact lenses according to subject's habitual prescription worn in both eyes and removed prior to sleep for cleaning and disinfection with the study product provided.
Device: AOSEPT Plus with HydraGlyde and AOCup lens case
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.
Other Names:
  • Clear Care Plus (CCP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Front surface deposits at Day 90
Time Frame: 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
Time Frame: 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
Time Frame: Up to Day 90
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
Time Frame: Up to Day 90
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
Incidence of solution induced corneal staining (SICS)
Time Frame: Up to Day 90
Corneal staining determined by the investigator to be solution-related will be graded by type (pattern of staining) and area (how much) in each of the 5 corneal regions: central, superior, nasal, inferior, temporal.
Up to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LCT783-P001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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