Sponsor study identifier
interventional
79
0 countries
N/A
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
December 15, 2011
Actual (reported)December 19, 2011
Actual (reported)July 2012
Actual (reported)July 2012
Actual (reported)September 27, 2013
Actual (reported)Maximum Papillae
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.
Baseline, Month 3
Maximum Eyelid Hyperaemia
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.
Baseline, Month 3
Upper Lid Redness
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.
Baseline, Month 3
Change From Baseline in Upper Eyelid Margin Staining at Month 3
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.
Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
Baseline, Month 3
Protective Index
Baseline, Month 3
Median Front Lens Deposits
Baseline, Month 3
Total Lipid Uptake Per Lens
Baseline, Month 3
Hydrogen peroxide-based contact lens care system used per manufacturer's instructions
PHMB-containing contact lens solution used per manufacturer's instructions
Michel Guillon, PhD, FCOptom, FAAO, CCTI
OTG Research & Consultancy
79 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2011
First Posted
December 19, 2011
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Baseline, Month 3
Contact lenses identical to habitual prescription worn per usual replacement regimen
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Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)Last Updated
September 27, 2013
Results First Posted
September 27, 2013
Record last verified: 2013-07
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Source: ClinicalTrials.gov.
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