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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01594294
First received: May 7, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention
Myopia
 Device: Hydrogen peroxide-based cleaning and disinfecting system (CLEAR CARE®/AOSEPT Plus)
Device: Polyaminopropyl biguanide (PHMB) multipurpose system (ReNu MultiPlus®)
Device: etafilcon A contact lens (ACUVUE® 2™)
Device: lotrafilcon B contact lens (AIR OPTIX® AQUA)

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
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change from Baseline in Papillae at Month 3 [ Time Frame: Baseline (Day 0), Month 3 ] [ Designated as safety issue: No ]
    Papillae (bumps) on the eyelid 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).

  • Change from Baseline in Lid Redness at Month 3 [ Time Frame: Baseline (Day 0), Month 3 ] [ 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.

  • Change from Baseline in Upper Lid Redness at Month 3 [ Time Frame: Baseline (Day 0), Month 3 ] [ 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.

  • Change from Baseline in Lid Margin Staining at Month 3 [ Time Frame: Baseline (Day 0), Month 3 ] [ Designated as safety issue: No ]
    After 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.


Secondary Outcome Measures:
  • Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) [ Time Frame: Month 3 ] [ 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: 100
Study Start Date: April 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLEAR CARE
CLEAR CARE contact lens cleaning and disinfecting system used in conjunction with etafilcon A study lenses or lotrafilcon B study lenses for 3 months.
 Device: Hydrogen peroxide-based cleaning and disinfecting system (CLEAR CARE®/AOSEPT Plus)
Contact lens cleaning and disinfecting care system used in conjunction with study contact lenses for 3 months. Product is CE-marked for the intended application.
Other Name: CLEAR CARE®/AOSEPT Plus
Device: etafilcon A contact lens (ACUVUE® 2™)
CE-marked, hydrogel contact lens worn on a daily wear basis for 3 months, with a fresh lens dispensed every two weeks.
Other Name: ACUVUE® 2™
Device: lotrafilcon B contact lens (AIR OPTIX® AQUA)
CE-marked, silicone hydrogel contact lens worn on a daily wear basis for 3 months, with a fresh lens dispensed every 4 weeks.
Other Name: AIR OPTIX® AQUA
Active Comparator: ReNu Multiplus
ReNu Multiplus multipurpose contact lens solution used in conjunction with etafilcon A study lenses or lotrafilcon B study lenses for 3 months.
 Device: Polyaminopropyl biguanide (PHMB) multipurpose system (ReNu MultiPlus®)
Contact lens multipurpose care system used in conjunction with study contact lenses for 3 months. Product is CE-marked for the intended application.
Other Name: ReNu MultiPlus®
Device: etafilcon A contact lens (ACUVUE® 2™)
CE-marked, hydrogel contact lens worn on a daily wear basis for 3 months, with a fresh lens dispensed every two weeks.
Other Name: ACUVUE® 2™
Device: lotrafilcon B contact lens (AIR OPTIX® AQUA)
CE-marked, silicone hydrogel contact lens worn on a daily wear basis for 3 months, with a fresh lens dispensed every 4 weeks.
Other Name: AIR OPTIX® AQUA

  Eligibility

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

Inclusion Criteria:

  • 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 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;
  • 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;
  • Use of any concomitant topical ocular medications during the study period;
  • Pregnant, planning to be become pregnant, or lactating at time of enrollment;
  • Participation in an investigational drug or device study within 30 days of entering study;
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594294

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations (UK)
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Director, Alcon Clinical Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01594294     History of Changes
Other Study ID Numbers: M-11-09
Study First Received: May 7, 2012
Last Updated: April 22, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
CLEAR CARE
AOSEPT Plus
ReNu MultiPlus
 silicone hydrogel
hydrogel
contact lenses

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
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