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: June 27, 2014
Last verified: June 2014

May 7, 2012
June 27, 2014
April 2012
June 2013   (final data collection date for primary outcome measure)
  • Maximum Papillae [ Time Frame: Baseline (Day 0), Month 3 ] [ Designated as safety issue: No ]
    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.
  • Maximum Eyelid Hyperaemia [ Time Frame: Baseline (Day 0), Month 3 ] [ Designated as safety issue: No ]
    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.
  • Mean Upper Eyelid Redness [ Time Frame: Baseline (Day 0), Month 3 ] [ Designated as safety issue: No ]
    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.
  • Mean Upper Eyelid Margin Staining [ Time Frame: Baseline (Day 0), Month 3 ] [ Designated as safety issue: No ]
    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.
  • 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
Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. Contact lenses were on-eye for this assessment.
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
EVALUATION OF THE EFFECTS OF CLEAR CARE® / AOSEPT® PLUS HYDROGEN PEROXIDE SOLUTION ON THE EYELID TISSUES - Part III: COMPARATIVE EVALUATION WITH RENU® MPS OVER 3 MONTH OF WEAR - CONTROL EVALUATION WITH AIR OPTIX® AQUA and ACUVUE® 2®

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.

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®.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Myopia
  • Device: AOSEPT® Plus contact lens solution
    Hydrogen peroxide-based cleaning and disinfection system
    Other Name: CLEAR CARE®
  • Device: ReNu MultiPlus® contact lens solution
    Polyaminopropyl biguanide (PHMB) preserved multipurpose solution
  • 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.
    Other Name: ACUVUE® 2®
  • 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.
    Other Name: AIR OPTIX® AQUA
  • Device: COMPLETE® MPS Easy Rub® Formula contact lens solution
    PHMB 0.0001% and poloxamer 0.05% multipurpose solution
  • Experimental: AOSEPT Plus
    AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
    Interventions:
    • Device: AOSEPT® Plus contact lens solution
    • Device: Etafilcon A contact lenses
    • Device: Lotrafilcon B contact lenses
  • Active Comparator: ReNu MultiPlus
    ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
    Interventions:
    • Device: ReNu MultiPlus® contact lens solution
    • Device: Etafilcon A contact lenses
    • Device: Lotrafilcon B contact lenses
  • 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
    Interventions:
    • Device: Etafilcon A contact lenses
    • Device: Lotrafilcon B contact lenses
    • Device: COMPLETE® MPS Easy Rub® Formula contact lens solution
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:

  • 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;
  • 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;
  • 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;
  • Other protocol-defined exclusion criteria may apply.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01594294
M-11-09
No
Alcon Research
Alcon Research
Not Provided
Study Director: Renee Garofalo, OD, FAAO Alcon Research
Alcon Research
June 2014

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