Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01494818
First received: December 15, 2011
Last updated: July 30, 2013
Last verified: July 2013

December 15, 2011
July 30, 2013
November 2011
July 2012   (final data collection date for primary outcome measure)
  • Maximum Papillae [ Time Frame: Baseline, 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.
  • Maximum Eyelid Hyperaemia [ Time Frame: Baseline, 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.
  • Upper Lid Redness [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    The contact lenses were removed and upper lid 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.
  • Change From Baseline in Upper Eyelid Margin Staining at Month 3 [ Time Frame: Baseline, 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.
  • 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.
Complete list of historical versions of study NCT01494818 on ClinicalTrials.gov Archive Site
  • Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT) [ Time Frame: Baseline, 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.
  • Protective Index [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis.
  • Median Front Lens Deposits [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis.
  • Total Lipid Uptake Per Lens [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface.
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
 
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 II: Comparative Evaluation With RENU MPS Over 3 Months of Wear

The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.

The subjects attended the enrollment visit having worn their habitual silicone hydrogel contact lenses for at least six hours on the day of the visit. The enrollment visit was scheduled so that the subjects' habitual lenses were at least 14 ± 3 days old for the subjects replacing their lenses bi-weekly and at least 30 ± 5 days old for those replacing their lenses monthly.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Contact Lens Care
  • Device: Hydrogen peroxide-based contact lens care system
    Other Name: CLEAR CARE®/AOSEPT Plus
  • Device: PHMB-containing contact lens solution
    Other Name: ReNu® MultiPlus Multi-Purpose solution
  • Device: Soft contact lenses
    Contact lenses identical to habitual prescription worn per usual replacement regimen
  • Experimental: CLEAR CARE/AOSEPT Plus
    Hydrogen peroxide-based contact lens care system used per manufacturer's instructions
    Interventions:
    • Device: Hydrogen peroxide-based contact lens care system
    • Device: Soft contact lenses
  • Active Comparator: ReNu MultiPlus
    PHMB-containing contact lens solution used per manufacturer's instructions
    Interventions:
    • Device: PHMB-containing contact lens solution
    • Device: Soft contact lenses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Read and understand Participant Information Sheet;
  • Read, sign, and date Informed Consent;
  • Successfully wearing silicone hydrogel contact lenses under a frequent replacement (biweekly or monthly) daily wear modality;
  • Using a PHMB-containing multipurpose contact lens solution;
  • Symptomatic, as specified in protocol;
  • 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 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01494818
ID 10-59 / M-11-02
No
Alcon Research
Alcon Research
Not Provided
Principal Investigator: Michel Guillon, PhD, FCOptom, FAAO, CCTI OTG Research & Consultancy
Alcon Research
July 2013

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