Contact Lens CareNCT06588400
AOSEPT (CLEAR CARE) PLUS Study
A study testing AOSEPT Plus and AOCup lens case, AOSEPT Plus with HydraGlyde and AOCup lens case and Habitual contact lenses in people with Contact Lens Care, run by Alcon Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Contact Lens Care
- What is being tested?
- AOSEPT Plus and AOCup lens case, AOSEPT Plus with HydraGlyde and AOCup lens case and Habitual contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: 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.
Read the 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.
- Conditions
- Contact Lens Care
- Being tested
- AOSEPT Plus and AOCup lens case, AOSEPT Plus with HydraGlyde and AOCup lens case, Habitual contact lenses
- Keywords
- Contact Lens Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOSEPT Plus and AOCup lens caseDevice
Also called Clear Care (CC)
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.
AOSEPT Plus with HydraGlyde and AOCup lens caseDevice
Also called Clear Care Plus (CCP)
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.
Habitual contact lensesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AOSEPT Plus and AOCup lens case; Device: 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. Receives: Device: AOSEPT Plus with HydraGlyde and AOCup lens case; Device: Habitual contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 90
Incidence of solution induced corneal staining (SICS)
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.
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Management decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588400
- Sponsor's protocol ID
- LCT783-P001
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06588400
- Acronym / sponsor ID
- LCT783-P001
- Conditions
- Contact Lens Care
- Keywords
- Contact Lens Solution
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOSEPT Plus (CC) | Experimental | Device: AOSEPT Plus and AOCup lens case, Device: Habitual contact lensesAOSEPT 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. |
| AOSEPT Plus with HydraGlyde (CCP) | Experimental | Device: AOSEPT Plus with HydraGlyde and AOCup lens case, Device: Habitual contact lensesAOSEPT 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AOSEPT Plus and AOCup lens caseAlso: Clear Care (CC)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. | Device | AOSEPT Plus (CC) |
| AOSEPT Plus with HydraGlyde and AOCup lens caseAlso: Clear Care Plus (CCP)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. | Device | AOSEPT Plus with HydraGlyde (CCP) |
| Habitual contact lensesDaily 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 (CC), AOSEPT Plus with HydraGlyde (CCP) |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Contact Lens Care
Enrolling by invitation
Smart Soft Contact Lenses for Monitoring Glaucoma
Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Vision Care study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOSEPT Plus and AOCup lens case, AOSEPT Plus with HydraGlyde and AOCup lens case and Habitual contact lenses in people with Contact Lens Care, run by Alcon Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Front surface deposits at Day 90 (time frame: Day 90). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.