Clinical trial NCT01594294: An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: CLEAR CARE®
AOSEPT® Plus
ReNu MultiPlus®
silicone hydrogel
hydrogel
ACUVUE® 2®
AIR OPTIX® AQUA
eyelid response
wettability
contamination
contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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®.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Papillae
timeFrame: Baseline (Day 0), Month 3
measure: Maximum Eyelid Hyperaemia
timeFrame: Baseline (Day 0), Month 3
measure: Mean Upper Eyelid Redness
timeFrame: Baseline (Day 0), Month 3
measure: Mean Upper Eyelid Margin Staining
timeFrame: Baseline (Day 0), Month 3
Secondary outcomes:
measure: Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
timeFrame: Month 3
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Renee Garofalo, OD, FAAO
role: STUDY_DIRECTOR
References: