Contact Lens CareNCT01494818
Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
A study testing Hydrogen peroxide-based contact lens care system, PHMB-containing contact lens solution and Soft contact lenses in people with Contact Lens Care, run by Alcon Research.
Trial summary
The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Care
- What is being tested?
- Hydrogen peroxide-based contact lens care system, PHMB-containing contact lens solution and Soft contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jul 2012
- 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
- Read and understand Participant Information Sheet;
- Read, sign, and date Informed Consent;
- Successfully wearing silicone hydrogel contact lenses under a frequent replacement (biweekly or monthly) daily wear modality;
- Using a PHMB-containing multipurpose contact lens solution;
- Symptomatic, as specified in protocol;
- Best corrected visual acuity of 6/9 or better in each eye;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any known sensitivity or intolerance to the contact lenses or len care products to be used;
- Systemic disease/medication which might interfere with contact lens wear or produce dry eye side effects;
- Ocular allergies or ocular disease which might interfere with contact lens wear;
- Use of any concomitant topical ocular medications during the study period;
- Participation in an investigational drug or device study within 30 days of entering the study;
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Evaluation of the Effects of Clear Care/AOSEPT Plus Hydrogen Peroxide Solution on the Eyelid Tissues - Part II: Comparative Evaluation With RENU MPS Over 3 Months of Wear
The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.
Read the detailed description
The subjects attended the enrollment visit having worn their habitual silicone hydrogel contact lenses for at least six hours on the day of the visit. The enrollment visit was scheduled so that the subjects' habitual lenses were at least 14 ± 3 days old for the subjects replacing their lenses bi-weekly and at least 30 ± 5 days old for those replacing their lenses monthly.
- Conditions
- Contact Lens Care
- Being tested
- Hydrogen peroxide-based contact lens care system, PHMB-containing contact lens solution, Soft contact lenses
- Keywords
- Contact lenses, Contact lens solutions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen peroxide-based contact lens care systemDevice
Also called CLEAR CARE®/AOSEPT Plus
PHMB-containing contact lens solutionDevice
Also called ReNu® MultiPlus Multi-Purpose solution
Soft contact lensesDevice
Contact lenses identical to habitual prescription worn per usual replacement regimen
| Study group | Role | What they receive |
|---|---|---|
| CLEAR CARE/AOSEPT Plus | Experimental | Hydrogen peroxide-based contact lens care system used per manufacturer's instructions Receives: Device: Hydrogen peroxide-based contact lens care system; Device: Soft contact lenses |
| ReNu MultiPlus | Active comparator | PHMB-containing contact lens solution used per manufacturer's instructions Receives: Device: PHMB-containing contact lens solution; Device: Soft contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Papillae
Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.
Measured: Baseline, Month 3
Maximum Eyelid Hyperaemia
Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis.
Measured: Baseline, Month 3
Upper Lid Redness
The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis.
Measured: Baseline, Month 3
Change From Baseline in Upper Eyelid Margin Staining at Month 3
The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis.
Measured: Baseline, Month 3
Secondary outcomes (4)
Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis.
Measured: Baseline, Month 3
Protective Index
A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis.
Measured: Baseline, Month 3
Median Front Lens Deposits
Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis.
Measured: Baseline, Month 3
Total Lipid Uptake Per Lens
The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionJul 2012
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 Contact Lens CareStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Guillon, PhD, FCOptom, FAAO, CCTI, Principal investigator, OTG Research & Consultancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494818
- Sponsor's protocol ID
- ID 10-59 / M-11-02
- Status last verified
- Jul 2013
- First submitted
- 15 Dec 2011
- Last updated
- 27 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Clear Care/AOSEPT Plus Hydrogen Peroxide Solution on the Eyelid Tissues - Part II: Comparative Evaluation With RENU MPS Over 3 Months of Wear
- ClinicalTrials.gov ID
- NCT01494818
- Acronym / sponsor ID
- ID 10-59 / M-11-02
- Conditions
- Contact Lens Care
- Keywords
- Contact lenses, Contact lens solutions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Posted 27 Sep 2013
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 was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.
Detailed description
The subjects attended the enrollment visit having worn their habitual silicone hydrogel contact lenses for at least six hours on the day of the visit. The enrollment visit was scheduled so that the subjects' habitual lenses were at least 14 ± 3 days old for the subjects replacing their lenses bi-weekly and at least 30 ± 5 days old for those replacing their lenses monthly.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLEAR CARE/AOSEPT Plus | Experimental | Device: Hydrogen peroxide-based contact lens care system, Device: Soft contact lensesHydrogen peroxide-based contact lens care system used per manufacturer's instructions |
| ReNu MultiPlus | Active comparator | Device: PHMB-containing contact lens solution, Device: Soft contact lensesPHMB-containing contact lens solution used per manufacturer's instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Read and understand Participant Information Sheet;
- Read, sign, and date Informed Consent;
- Successfully wearing silicone hydrogel contact lenses under a frequent replacement (biweekly or monthly) daily wear modality;
- Using a PHMB-containing multipurpose contact lens solution;
- Symptomatic, as specified in protocol;
Key exclusion criteria (6 listed)
- Any known sensitivity or intolerance to the contact lenses or len care products to be used;
- Systemic disease/medication which might interfere with contact lens wear or produce dry eye side effects;
- Ocular allergies or ocular disease which might interfere with contact lens wear;
- Use of any concomitant topical ocular medications during the study period;
- Participation in an investigational drug or device study within 30 days of entering 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 |
|---|---|---|
| Hydrogen peroxide-based contact lens care systemAlso: CLEAR CARE®/AOSEPT Plus | Device | CLEAR CARE/AOSEPT Plus |
| PHMB-containing contact lens solutionAlso: ReNu® MultiPlus Multi-Purpose solution | Device | ReNu MultiPlus |
| Soft contact lensesContact lenses identical to habitual prescription worn per usual replacement regimen | Device | CLEAR CARE/AOSEPT Plus, ReNu MultiPlus |
Primary outcome
Maximum Papillae
Time frame: Baseline, Month 3
Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.
Maximum Eyelid Hyperaemia
Time frame: Baseline, Month 3
Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis.
Upper Lid Redness
Time frame: Baseline, Month 3
The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis.
Change From Baseline in Upper Eyelid Margin Staining at Month 3
Time frame: Baseline, Month 3
The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis.
4 secondary outcomes
Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
Time frame: Baseline, Month 3
Protective Index
Time frame: Baseline, Month 3
Median Front Lens Deposits
Time frame: Baseline, Month 3
Total Lipid Uptake Per Lens
Time frame: Baseline, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Michel Guillon, PhD, FCOptom, FAAO, CCTI principal investigator
OTG Research & Consultancy
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen peroxide-based contact lens care system, PHMB-containing contact lens solution and Soft contact lenses in people with Contact Lens Care, 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 7 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: finished, as of the sponsor's last update on 27 Sep 2013. 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 27 Sep 2013). 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?
Maximum Papillae (time frame: Baseline, Month 3). The study lists 4 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 27 Sep 2013.