An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues (ID11-56)

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: ReNu MultiPlus® contact lens solution; Device: COMPLETE® MPS Easy Rub® Formula contact lens solution; Device: Etafilcon A contact lenses; Device: AOSEPT® Plus contact lens solution; Device: Lotrafilcon B contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01594294

M-11-09

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

AOSEPT Plus

Experimental group

Description:

AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)

Treatment:

Device: Lotrafilcon B contact lenses

Device: AOSEPT® Plus contact lens solution

Device: Etafilcon A contact lenses

ReNu MultiPlus

Active Comparator group

Description:

ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)

Treatment:

Device: ReNu MultiPlus® contact lens solution

Device: Lotrafilcon B contact lenses

Device: Etafilcon A contact lenses

Complete MPS Easy Rub

Other group

Description:

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

Treatment:

Device: Lotrafilcon B contact lenses

Device: Etafilcon A contact lenses

Device: COMPLETE® MPS Easy Rub® Formula contact lens solution