Refractive ErrorNCT02413333
Clear Care® Plus vs. PeroxiClear™
A study testing Clear Care Plus contact lens solution, PeroxiClear contact lens solution and Silicone hydrogel contact lenses in people with Refractive Error, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Error
- What is being tested?
- Clear Care Plus contact lens solution, PeroxiClear contact lens solution and Silicone hydrogel contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent form;
- Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);
- Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;
- Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Current hydrogen peroxide-based solution user;
- Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers
The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.
Read the detailed description
Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.
- Conditions
- Refractive Error
- Being tested
- Clear Care Plus contact lens solution, PeroxiClear contact lens solution, Silicone hydrogel contact lenses
- Keywords
- Contact lens solution
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Care Plus contact lens solutionDevice
Also called Clear Care Plus
3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses
PeroxiClear contact lens solutionDevice
Also called PeroxiClear
3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses
Silicone hydrogel contact lensesDevice
2-week/monthly replacement contact lenses per participant's habitual brand
| Study group | Role | What they receive |
|---|---|---|
| Clear Care Plus, then PeroxiClear | Other | Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles. Receives: Device: Clear Care Plus contact lens solution; Device: PeroxiClear contact lens solution; Device: Silicone hydrogel contact lenses |
| PeroxiClear, then Clear Care Plus | Other | PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles. Receives: Device: Clear Care Plus contact lens solution; Device: PeroxiClear contact lens solution; Device: Silicone hydrogel contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Residual Peroxide at Day 30
The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
Measured: Day 30, each product
Secondary outcomes (1)
Mean Osmolality in Lens Cases at Day 30
The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
Measured: Day 30, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractive ErrorStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Manager, Vision Care, Global Medical Affairs, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413333
- Sponsor's protocol ID
- LCD913-P001
- Status last verified
- Jul 2016
- First submitted
- 7 Apr 2015
- Last updated
- 19 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT02413333
- Acronym / sponsor ID
- LCD913-P001
- Conditions
- Refractive Error
- Keywords
- Contact lens solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Posted 19 Sep 2016
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 study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.
Detailed description
Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear Care Plus, then PeroxiClear | Other | Device: Clear Care Plus contact lens solution, Device: PeroxiClear contact lens solution, Device: Silicone hydrogel contact lensesClear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles. |
| PeroxiClear, then Clear Care Plus | Other | Device: Clear Care Plus contact lens solution, Device: PeroxiClear contact lens solution, Device: Silicone hydrogel contact lensesPeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign informed consent form;
- Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);
- Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;
- Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (8 listed)
- Current hydrogen peroxide-based solution user;
- Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated;
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 |
|---|---|---|
| Clear Care Plus contact lens solutionAlso: Clear Care Plus3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses | Device | Clear Care Plus, then PeroxiClear, PeroxiClear, then Clear Care Plus |
| PeroxiClear contact lens solutionAlso: PeroxiClear3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses | Device | Clear Care Plus, then PeroxiClear, PeroxiClear, then Clear Care Plus |
| Silicone hydrogel contact lenses2-week/monthly replacement contact lenses per participant's habitual brand | Device | Clear Care Plus, then PeroxiClear, PeroxiClear, then Clear Care Plus |
Primary outcome
Mean Residual Peroxide at Day 30
Time frame: Day 30, each product
The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
1 secondary outcome
Mean Osmolality in Lens Cases at Day 30
Time frame: Day 30, each product
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Refractive Error
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Not yet recruiting
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
Refractive Errors
Not yet recruiting
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
Refractive Errors
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 Manager, Vision Care, Global Medical Affairs study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Clear Care Plus contact lens solution, PeroxiClear contact lens solution and Silicone hydrogel contact lenses in people with Refractive Error, run by Alcon Research.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 19 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Residual Peroxide at Day 30 (time frame: Day 30, each product). 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 19 Sep 2016.