- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594294
An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues (ID11-56)
June 27, 2014 updated by: Alcon Research
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®
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.
Study Overview
Status
Completed
Conditions
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®.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AOSEPT Plus
AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
Hydrogen peroxide-based cleaning and disinfection system
Other Names:
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.
Other Names:
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.
Other Names:
|
Active Comparator: ReNu MultiPlus
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
|
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.
Other Names:
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.
Other Names:
Polyaminopropyl biguanide (PHMB) preserved multipurpose solution
|
Other: Complete MPS Easy Rub
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
|
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.
Other Names:
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.
Other Names:
PHMB 0.0001% and poloxamer 0.05% multipurpose solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (Day 0), Month 3
|
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.
|
Baseline (Day 0), Month 3
|
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.
|
Baseline (Day 0), Month 3
|
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.
|
Baseline (Day 0), Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
Time Frame: Month 3
|
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.
|
Month 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Renee Garofalo, OD, FAAO, Alcon Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
May 7, 2012
First Submitted That Met QC Criteria
May 7, 2012
First Posted (Estimate)
May 9, 2012
Study Record Updates
Last Update Posted (Estimate)
July 25, 2014
Last Update Submitted That Met QC Criteria
June 27, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-11-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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