An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

NCT ID: NCT01594294

Last Updated: 2014-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-06-30

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®.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

AOSEPT Plus

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

Group Type: EXPERIMENTAL

AOSEPT® Plus contact lens solution

Intervention Type: DEVICE

Hydrogen peroxide-based cleaning and disinfection system

Etafilcon A contact lenses

Intervention Type: DEVICE

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 lenses

Intervention Type: DEVICE

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.

ReNu MultiPlus

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

Group Type: ACTIVE_COMPARATOR

ReNu MultiPlus® contact lens solution

Intervention Type: DEVICE

Polyaminopropyl biguanide (PHMB) preserved multipurpose solution

Etafilcon A contact lenses

Intervention Type: DEVICE

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 lenses

Intervention Type: DEVICE

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

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

Group Type: OTHER

Etafilcon A contact lenses

Intervention Type: DEVICE

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 lenses

Intervention Type: DEVICE

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 solution

Intervention Type: DEVICE

PHMB 0.0001% and poloxamer 0.05% multipurpose solution

Interventions

AOSEPT® Plus contact lens solution

Hydrogen peroxide-based cleaning and disinfection system

Intervention Type: DEVICE

ReNu MultiPlus® contact lens solution

Polyaminopropyl biguanide (PHMB) preserved multipurpose solution

Intervention Type: DEVICE

Etafilcon A contact lenses

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.

Intervention Type: DEVICE

Lotrafilcon B contact lenses

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.

Intervention Type: DEVICE

COMPLETE® MPS Easy Rub® Formula contact lens solution

PHMB 0.0001% and poloxamer 0.05% multipurpose solution

Intervention Type: DEVICE

Other Intervention Names

CLEAR CARE®; ACUVUE® 2®; AIR OPTIX® AQUA

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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renee Garofalo, OD, FAAO

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M-11-09

Identifier Type: -

Identifier Source: org_study_id