7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers
Corneal Staining Evaluation of SiH MPDS FID 114675A
Corneal Staining Evaluation of SiH MPDS FID 114675A
Sponsor study identifier
interventional
110
0 countries
N/A
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Actual (reported)Study Completion
June 2009
Actual (reported)The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2009
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.
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 17, 2009
Actual (reported)April 21, 2009
Actual (reported)June 2009
Actual (reported)June 2009
Actual (reported)March 22, 2012
Actual (reported)Solution-Related Corneal Staining
Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.
Day 7
Mean Lens Comfort
Day 7
FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only.
Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses
Commercially marketed hydrogel contact lens for daily wear use
110 participants (actual enrollment reported by the registry).
First Submitted
April 17, 2009
First Posted
April 21, 2009
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Commercially marketed silicone hydrogel contact lens for daily wear use
Commercially marketed silicone hydrogel contact lens for daily wear use
Commercially marketed silicone hydrogel contact lens for daily wear use
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2009
Actual (reported)Study Completion
June 2009
Actual (reported)Last Updated
March 27, 2012
Results First Posted
March 22, 2012
Record last verified: 2012-03
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Source: ClinicalTrials.gov.
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