PresbyopiaNCT02965833
CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers
A study testing 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix, Habitual Multi-Purpose Contact Lens Solution and Habitual Contact Lenses in people with Presbyopia, run by Alcon, a Novartis Company.
Trial summary
The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix, Habitual Multi-Purpose Contact Lens Solution and Habitual Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 13 Dec 2016to 24 Mar 2017
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must sign an informed consent document;
- Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
- Near spectacle add of +0.50 or greater;
- Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
- Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
- Currently (at least 2 months) using a non-HYDRAGLYDE® containing multi-purpose solution (OPTI-FREE® PureMoist® is excluded) to care for lenses;
- Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
- Other protocol-specific inclusion criteria may apply.
Who cannot join
- Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Known sensitivity to any ingredients in CLEAR CARE® PLUS (CCP);
- Prior refractive surgery;
Show all 12Show fewer
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pathological dry eye that precludes contact lens wear;
- Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- Participation in any clinical study within 30 days of Visit 1;
- Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;
- Other protocol-specific exclusion criteria may apply.
About this study
Official title: Clinical Study of CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers
The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.
- Conditions
- Presbyopia
- Being tested
- 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix, Habitual Multi-Purpose Contact Lens Solution, Habitual Contact Lenses
- Keywords
- Contact lens induced dryness
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% hydrogen peroxide solution with HydraGlyde® Moisture MatrixDevice
Also called CLEAR CARE® PLUS
For cleaning, disinfection and overnight storage of contact lenses
Habitual Multi-Purpose Contact Lens SolutionDevice
Habitual Contact LensesDevice
Participant's habitual contact lens brand worn in a daily wear modality for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| CCP, then HMPS | Other | 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. Receives: Device: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix; Device: Habitual Multi-Purpose Contact Lens Solution; Device: Habitual Contact Lenses |
| HMPS, then CCP | Other | Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. Receives: Device: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix; Device: Habitual Multi-Purpose Contact Lens Solution; Device: Habitual Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.
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 posted17 Nov 2016 (estimated)
- Study start13 Dec 2016
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
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 PresbyopiaStudies 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon, a Novartis Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Project Manager, CPM, Study director, Alcon, A Novartis Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965833
- Sponsor's protocol ID
- LCS739-P001
- Status last verified
- Jun 2018
- First submitted
- 15 Nov 2016
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT02965833
- Acronym / sponsor ID
- LCS739-P001
- Conditions
- Presbyopia
- Keywords
- Contact lens induced dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Alcon, a Novartis CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Posted 26 Apr 2018
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 (CCP) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCP, then HMPS | Other | Device: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix, Device: Habitual Multi-Purpose Contact Lens Solution, Device: Habitual Contact Lenses3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. |
| HMPS, then CCP | Other | Device: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix, Device: Habitual Multi-Purpose Contact Lens Solution, Device: Habitual Contact LensesSubject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must sign an informed consent document;
- Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
- Near spectacle add of +0.50 or greater;
- Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
- Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
Key exclusion criteria (12 listed)
- Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Known sensitivity to any ingredients in CLEAR CARE® PLUS (CCP);
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 |
|---|---|---|
| 3% hydrogen peroxide solution with HydraGlyde® Moisture MatrixAlso: CLEAR CARE® PLUSFor cleaning, disinfection and overnight storage of contact lenses | Device | CCP, then HMPS, HMPS, then CCP |
| Habitual Multi-Purpose Contact Lens Solution | Device | CCP, then HMPS, HMPS, then CCP |
| Habitual Contact LensesParticipant's habitual contact lens brand worn in a daily wear modality for 30 days. | Device | CCP, then HMPS, HMPS, then CCP |
Primary outcome
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
Time frame: Day 30, each product
CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Project Manager, CPM study director
Alcon, A Novartis Division
Questions about this trial
What is this clinical trial studying?
A study testing 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix, Habitual Multi-Purpose Contact Lens Solution and Habitual Contact Lenses in people with Presbyopia, run by Alcon, a Novartis Company.
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 8 inclusion and 12 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 11 Jul 2018. 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 26 Apr 2018). 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?
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score 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 11 Jul 2018.