NCT01240135|CompletedResults
Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A
Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A
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Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A
Sponsor study identifier
interventional
89
0 countries
N/A
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2011
Actual (reported)Study Completion
February 2011
Actual (reported)The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2011
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.
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
November 10, 2010
Actual (reported)November 15, 2010
Actual (reported)February 2011
Actual (reported)February 2011
Actual (reported)July 12, 2012
Actual (reported)Lens Fit
As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
Day 14 of lens wear
Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score
Day 14 of lens wear
FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
89 participants (actual enrollment reported by the registry).
First Submitted
November 10, 2010
First Posted
November 15, 2010
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens
Evaluation of the Feasibility a New Silicone Hydrogel Contact Lens
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
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
February 2011
Actual (reported)Study Completion
February 2011
Actual (reported)Last Updated
July 12, 2012
Results First Posted
July 12, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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