Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues - Full Text View

Purpose

The purpose of this study is to assess and compare the effect of two contact lens care systems used in conjunction with silicone hydrogel contact lenses worn on a daily wear basis for three months.

Condition	Intervention
Contact Lens Care	Device: Hydrogen peroxide-based contact lens care system (CLEAR CARE®/AOSEPT Plus) Device: Polyaminopropyl biguanide (PHMB) containing multipurpose system (ReNu® ) Device: Soft contact lenses

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

Drug Information available for: Hydrogen peroxide

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Change at 3 months from baseline, papillae [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Papillae will be subjectively rated by the investigator for the 4 palpebral zones (upper lid = 1-3; lower lid = 4) using a 5-point scale: 0 = none; 1 = slight (diffuse papillae); 2 = mild (diffuse and tufts papillae); 3 = moderate (moderate and tufts papillae); 4 = severe (giant papillae). The data recorded at the 3-month visit will be compared to the data recorded at the baseline visit.
Change at 3 months from baseline, lid redness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Lid redness will be subjectively rated by the investigator for the 4 palpebral zones (upper lid = 1-3; lower lid = 4) using a 5-point scale: 0 = clear; 1 = slight redness; 2 = mild redness; 3 = moderate redness; 4 = severe redness. The data recorded at the 3-month visit will be compared to the data recorded at the baseline visit.
Change at 3 months from baseline, upper lid redness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Upper lid redness will be objectively measured through digital images. The area covered by blood vessels will be compared to the total area of measurement. The data recorded at the 3-month visit will be compared to the data recorded at the baseline visit.
Change at 3 months from baseline, lid margin staining [ Time Frame: 3 months ] [ Designated as safety issue: No ]
After the instillation of dye, lid margin staining will be objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) will be measured. The data recorded at the 3-month visit will be compared to the data recorded at the baseline visit.

Secondary Outcome Measures:

Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
NIBUT will be evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. NIBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film.

Enrollment:	79
Study Start Date:	November 2011
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CLEAR CARE/AOSEPT Plus Used per manufacturer's instruction for cleaning, disinfecting, neutralizing, removing protein, and storing all types of contact lenses, including silicone hydrogel	Device: Hydrogen peroxide-based contact lens care system (CLEAR CARE®/AOSEPT Plus) Contact lens solution system CE-marked for the intended application Other Name: CLEAR CARE®/AOSEPT Plus Device: Soft contact lenses Contact lenses identical to habitual prescription worn per usual replacement regimen
Active Comparator: ReNu MultiPlus Used per manufacturer's instructions for cleaning, rinsing, and disinfecting soft contact lenses	Device: Polyaminopropyl biguanide (PHMB) containing multipurpose system (ReNu® ) Contact lens solution system CE-marked for the intended application Other Name: ReNu® MultiPlus Multi-Purpose solution Device: Soft contact lenses Contact lenses identical to habitual prescription worn per usual replacement regimen

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Note: Study site located in London, UK

Inclusion Criteria:

18 years or older.
Successfully wearing a silicone hydrogel contact lens in conjunction with a PHMB containing multipurpose solution under a frequent replacement (biweekly or monthly) daily wear modality.
Symptomatic wearer.
Best corrected visual acuity of 6/9 or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any known sensitivity or intolerance to the contact lenses or contact len care products to be used.
Systemic disease/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.
Use of any concomitant topical ocular medications during the study period.
Participation in an investigational drug or device study within 30 days of entering the study.
Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494818

Locations

United States, Texas
Call Alcon Call Center for Trial Location
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators

Principal Investigator:

Michel Guillon, PhD, FCOptom, FAAO, CCTI

OTG Research & Consultancy

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01494818 History of Changes
Other Study ID Numbers:	ID 10-59 / M-11-02
Study First Received:	December 15, 2011
Last Updated:	August 8, 2012
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:

Contact lenses
Contact lens solutions

Additional relevant MeSH terms:

Hydrogen Peroxide
Contact Lens Solutions
Anti-Infective Agents, Local
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Disinfectants

ClinicalTrials.gov processed this record on May 19, 2013