Sponsor study identifier
interventional
40
0 countries
N/A
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)The purpose of this study is to clinically evaluate an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 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)May 2009
Actual (reported)May 2009
Actual (reported)March 20, 2012
Actual (reported)Mean Ex-Vivo Wetting Angle
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Day 7, Hour 14
Mean Lens Comfort
Day 7, Hour 14
Percentage of Participants With Solution-Related Corneal Staining
Day 7, Hour 14
FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.
Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.
40 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
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
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Last Updated
March 27, 2012
Results First Posted
March 20, 2012
Record last verified: 2012-03
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Source: ClinicalTrials.gov.
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