MyopiaID11-56NCT01594294

An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

A study testing AOSEPT® Plus contact lens solution, ReNu MultiPlus® contact lens solution and Etafilcon A contact lenses in people with Myopia, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to assess and compare the effect of the repeated usage of 2 different care systems (one hydrogen peroxide based cleaning and disinfecting system and one PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn on a daily wear basis for a 3-month period. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: AOSEPT® Plus contact lens solution, ReNu MultiPlus® contact lens solution and Etafilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: Apr 2012to Jun 2013
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 the Participant Information Sheet;
Read, sign, and date an Informed Consent;
Successfully wearing a frequent replacement hydrogel or silicone hydrogel contact lens brand under a frequent replacement (biweekly or monthly) daily wear modality;
Classified as symptomatic according to protocol-specified criteria;
Agree to wear study contact lenses as directed for the duration of the study;
Best corrected visual acuity (BCVA) of 6/9 or better in each eye;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
History of seasonal allergies, which may have an adverse impact on contact lens wear, or data and information obtained in this study;
Systemic disease or use of 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 or data and information obtained in this study;
Active ocular infection;

Show all 15Show fewer

Use of any concomitant topical ocular medications during the study period;
Significant ocular anomaly;
Previous ocular surgery;
History of recent, significant changes in visual acuity;
Any medical condition that might be prejudicial to the study;
Pregnant, planning to be become pregnant, or lactating at time of enrollment;
Any infectious disease (e.g. hepatitis, tuberculosis), immunosuppressive disease (e.g. HIV), or diabetes;
Participation in an investigational drug or device study within 30 days of entering 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 III: COMPARATIVE EVALUATION WITH RENU® MPS OVER 3 MONTH OF WEAR - CONTROL EVALUATION WITH AIR OPTIX® AQUA and ACUVUE® 2®

Read the detailed description

This study was divided into 2 periods, a Screening Phase and an Investigational Phase. During the Screening Phase, subjects were fitted and dispensed with either ACUVUE® 2® (for current hydrogel wearers) or AIR OPTIX® AQUA (for current silicone hydrogel wearers) contact lenses and used COMPLETE® MPS Easy Rub® Formula to clean and disinfect their lenses. At the completion of the Screening Phase, the symptomatic status of the subjects was re-assessed. Those subjects who qualified proceeded to the Investigational Phase and were dispensed with new pair of study contact lenses identical to the lenses they wore during the Screening Phase to use in conjunction with the allocated study care product, CLEAR CARE® /AOSEPT® Plus or ReNu MultiPlus®.

Conditions: Myopia
Being tested: AOSEPT® Plus contact lens solution, ReNu MultiPlus® contact lens solution, Etafilcon A contact lenses, Lotrafilcon B contact lenses, COMPLETE® MPS Easy Rub® Formula contact lens solution
Keywords: CLEAR CARE®, AOSEPT® Plus, ReNu MultiPlus®, silicone hydrogel, hydrogel, ACUVUE® 2®, AIR OPTIX® AQUA, eyelid response, wettability, contamination, contact lenses
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AOSEPT® Plus contact lens solutionDevice
Also called CLEAR CARE®
Hydrogen peroxide-based cleaning and disinfection system
ReNu MultiPlus® contact lens solutionDevice
Polyaminopropyl biguanide (PHMB) preserved multipurpose solution
Etafilcon A contact lensesDevice
Also called ACUVUE® 2®
Hydrogel contact lenses worn on a daily wear basis for 14 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed every 2 weeks.
Lotrafilcon B contact lensesDevice
Also called AIR OPTIX® AQUA
Silicone hydrogel contact lenses worn on a daily wear basis for 30 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed monthly.
COMPLETE® MPS Easy Rub® Formula contact lens solutionDevice
PHMB 0.0001% and poloxamer 0.05% multipurpose solution

Study groups in NCT01594294
Study group	Role	What they receive
AOSEPT Plus	Experimental	AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase) Receives: Device: AOSEPT® Plus contact lens solution; Device: Etafilcon A contact lenses; Device: Lotrafilcon B contact lenses
ReNu MultiPlus	Active comparator	ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase) Receives: Device: ReNu MultiPlus® contact lens solution; Device: Etafilcon A contact lenses; Device: Lotrafilcon B contact lenses
Complete MPS Easy Rub	Other	COMPLETE® MPS Easy Rub® Formula contact lens solution used with etafilcon A contact lenses (14 days) or lotrafilcon B contact lenses (30 days), Screening Phase Receives: Device: Etafilcon A contact lenses; Device: Lotrafilcon B contact lenses; Device: COMPLETE® MPS Easy Rub® Formula contact lens solution

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. Contact lenses were not worn for this assessment.
Measured: Baseline (Day 0), 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. Contact lenses were not worn for this assessment.
Measured: Baseline (Day 0), Month 3
Mean Upper Eyelid Redness
The contact lenses were removed and upper eyelid 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. Contact lenses were not worn for this assessment.
Measured: Baseline (Day 0), Month 3
Mean Upper Eyelid Margin Staining
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. Contact lenses were not worn for this assessment.
Measured: Baseline (Day 0), Month 3

Secondary outcomes (1)

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. Contact lenses were on-eye for this assessment.
Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Jun 2013

First posted9 May 2012 (estimated)
Study startApr 2012
Primary completionJun 2013
Study completionJun 2013

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 MyopiaStudies 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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01594294
Sponsor's protocol ID: M-11-09
Acronym: ID11-56
Status last verified: Jun 2014
First submitted: 7 May 2012
Last updated: 25 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2014. 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 III: COMPARATIVE EVALUATION WITH RENU® MPS OVER 3 MONTH OF WEAR - CONTROL EVALUATION WITH AIR OPTIX® AQUA and ACUVUE® 2®
ClinicalTrials.gov ID: NCT01594294
Acronym / sponsor ID: ID11-56 / M-11-09
Conditions: Myopia
Keywords: CLEAR CARE®, AOSEPT® Plus, ReNu MultiPlus®, silicone hydrogel, hydrogel, ACUVUE® 2®, AIR OPTIX® AQUA, eyelid response
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 9 May 2012 (estimated)
Results: Posted 25 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
AOSEPT Plus	Experimental	Device: AOSEPT® Plus contact lens solution, Device: Etafilcon A contact lenses, Device: Lotrafilcon B contact lensesAOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
ReNu MultiPlus	Active comparator	Device: ReNu MultiPlus® contact lens solution, Device: Etafilcon A contact lenses, Device: Lotrafilcon B contact lensesReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
Complete MPS Easy Rub	Other	Device: Etafilcon A contact lenses, Device: Lotrafilcon B contact lenses, Device: COMPLETE® MPS Easy Rub® Formula contact lens solutionCOMPLETE® MPS Easy Rub® Formula contact lens solution used with etafilcon A contact lenses (14 days) or lotrafilcon B contact lenses (30 days), Screening Phase

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 the Participant Information Sheet;
Read, sign, and date an Informed Consent;
Successfully wearing a frequent replacement hydrogel or silicone hydrogel contact lens brand under a frequent replacement (biweekly or monthly) daily wear modality;
Classified as symptomatic according to protocol-specified criteria;
Agree to wear study contact lenses as directed for the duration of the study;

Key exclusion criteria (15 listed)

Any known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
History of seasonal allergies, which may have an adverse impact on contact lens wear, or data and information obtained in this study;
Systemic disease or use of 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 or data and information obtained in this 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 contact lens solutionAlso: CLEAR CARE®Hydrogen peroxide-based cleaning and disinfection system	Device	AOSEPT Plus
ReNu MultiPlus® contact lens solutionPolyaminopropyl biguanide (PHMB) preserved multipurpose solution	Device	ReNu MultiPlus
Etafilcon A contact lensesAlso: ACUVUE® 2®Hydrogel contact lenses worn on a daily wear basis for 14 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed every 2 weeks.	Device	AOSEPT Plus, Complete MPS Easy Rub, ReNu MultiPlus
Lotrafilcon B contact lensesAlso: AIR OPTIX® AQUASilicone hydrogel contact lenses worn on a daily wear basis for 30 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed monthly.	Device	AOSEPT Plus, Complete MPS Easy Rub, ReNu MultiPlus
COMPLETE® MPS Easy Rub® Formula contact lens solutionPHMB 0.0001% and poloxamer 0.05% multipurpose solution	Device	Complete MPS Easy Rub

Primary outcome

Maximum Papillae
Time frame: Baseline (Day 0), 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. Contact lenses were not worn for this assessment.
Maximum Eyelid Hyperaemia
Time frame: Baseline (Day 0), 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. Contact lenses were not worn for this assessment.
Mean Upper Eyelid Redness
Time frame: Baseline (Day 0), Month 3
The contact lenses were removed and upper eyelid 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. Contact lenses were not worn for this assessment.
Mean Upper Eyelid Margin Staining
Time frame: Baseline (Day 0), 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. Contact lenses were not worn for this assessment.

1 secondary outcome

Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
Time frame: Month 3

Results and safety

Results posted to the registry on 25 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AOSEPT Plus	39	36
ReNu MultiPlus	40	36

Primary outcome: Maximum Papillae

Time frame: Baseline (Day 0), Month 3. Median (Full Range). Unit: Units on a scale

Measure	AOSEPT Plus n = 35	ReNu MultiPlus n = 36
Baseline (Day 0)	1.50 (.50 to 3.00)	1.00 (.00 to 3.00)
Month 3	1.50 (.50 to 3.00)	1.00 (.00 to 3.00)

Population analysed: This analysis population includes all participants who completed the study as per the protocol, minus missing responses.

Primary outcome: Maximum Eyelid Hyperaemia

Time frame: Baseline (Day 0), Month 3. Median (Full Range). Unit: units on a scale

Measure	AOSEPT Plus n = 35	ReNu MultiPlus n = 36
Baseline (Day 0)	2.00 (1.00 to 3.00)	2.00 (1.00 to 3.50)
Month 3	2.00 (1.50 to 4.00)	2.00 (1.00 to 3.00)

Population analysed: This analysis population includes all participants who completed the study as per the protocol, minus missing responses.

Primary outcome: Mean Upper Eyelid Redness

Time frame: Baseline (Day 0), Month 3. Mean (Standard Deviation). Unit: percentage of total surface measured

Measure	AOSEPT Plus n = 35	ReNu MultiPlus n = 36
Baseline (Day 0)	34.7 (15.5)	31.9 (9.1)
Month 3	33.4 (13.4)	30.8 (12.7)

Population analysed: This analysis population includes all participants who completed the study as per the protocol, minus missing responses.

Primary outcome: Mean Upper Eyelid Margin Staining

Time frame: Baseline (Day 0), Month 3. Mean (Standard Deviation). Unit: square millimeters

Measure	AOSEPT Plus n = 35	ReNu MultiPlus n = 36
Baseline (Day 0)	5.36 (4.21)	4.33 (2.65)
Month 3	4.49 (2.90)	4.80 (2.82)

Population analysed: This analysis population includes all participants who completed the study as per the protocol, minus missing responses.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AOSEPT Plus	2 of 39 (5.1%)	3 of 39 (7.7%)	Not reported
ReNu MultiPlus	2 of 39 (5.1%)	0 of 39 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
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Not yet recruiting
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Not yet recruiting
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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.

Renee Garofalo, OD, FAAO study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing AOSEPT® Plus contact lens solution, ReNu MultiPlus® contact lens solution and Etafilcon A contact lenses in people with Myopia, 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 15 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 25 Jul 2014. 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 25 Jul 2014). 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 (Day 0), 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?

On the ClinicalTrials.gov record for NCT01594294.

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 25 Jul 2014.