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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01594294
First received: May 7, 2012
Last updated: July 2, 2013
Last verified: July 2013

May 7, 2012
July 2, 2013
April 2012
June 2013   (final data collection date for primary outcome measure)
  • 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.
  • Change at 3 months from baseline, papillae [ Time Frame: Baseline, 3 months ] [ 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). 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: Baseline, 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: Baseline, 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: Baseline, 3 months ] [ 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. The data recorded at the 3-month visit will be compared to the data recorded at the baseline visit.
Complete list of historical versions of study NCT01594294 on ClinicalTrials.gov Archive Site
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.
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.
Not Provided
Not Provided
 
An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Myopia
  • 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: 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
  • 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.
    Interventions:
    • Device: Hydrogen peroxide-based cleaning and disinfecting system (CLEAR CARE®/AOSEPT Plus)
    • Device: etafilcon A contact lens (ACUVUE® 2™)
    • Device: lotrafilcon B contact lens (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.
    Interventions:
    • Device: Polyaminopropyl biguanide (PHMB) multipurpose system (ReNu MultiPlus®)
    • Device: etafilcon A contact lens (ACUVUE® 2™)
    • Device: lotrafilcon B contact lens (AIR OPTIX® AQUA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01594294
M-11-09
No
Alcon Research
Alcon Research
Not Provided
Study Director: Director, Alcon Clinical Alcon Research
Alcon Research
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP