An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

NCT01594294 | Completed Results

• 1 other identifier: M-11-09
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia

Keywords

CLEAR CARE®; AOSEPT® Plus; ReNu MultiPlus®; silicone hydrogel; hydrogel; ACUVUE® 2®; AIR OPTIX® AQUA; eyelid response; wettability; contamination; contact lenses

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline (Day 0), Month 3

Secondary Outcomes (1)

• Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)

  Month 3

Study Arms (3)

AOSEPT Plus

EXPERIMENTAL

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

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)

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

Device: Etafilcon A contact lenses; Device: Lotrafilcon B contact lenses; Device: COMPLETE® MPS Easy Rub® Formula contact lens solution

Interventions

AOSEPT® Plus contact lens solution DEVICE

Hydrogen peroxide-based cleaning and disinfection system

Also known as: CLEAR CARE®

AOSEPT Plus

ReNu MultiPlus® contact lens solution DEVICE

Polyaminopropyl biguanide (PHMB) preserved multipurpose solution

ReNu MultiPlus

Etafilcon A contact lenses 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.

Also known as: ACUVUE® 2®

AOSEPT Plus; Complete MPS Easy Rub; ReNu MultiPlus

Lotrafilcon B contact lenses 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.

Also known as: AIR OPTIX® AQUA

AOSEPT Plus; Complete MPS Easy Rub; ReNu MultiPlus

COMPLETE® MPS Easy Rub® Formula contact lens solution DEVICE

PHMB 0.0001% and poloxamer 0.05% multipurpose solution

Complete MPS Easy Rub

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Renee Garofalo, OD, FAAO
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Renee Garofalo, OD, FAAO

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 9, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 25, 2014
• Results First Posted: July 25, 2014

Record last verified: 2014-06