Sponsor study identifier
interventional
396
1 country
1
Study Start
May 31, 2015
Actual (reported)Primary Completion
October 31, 2015
Actual (reported)Study Completion
October 31, 2015
Actual (reported)The objective of this study is to evaluate the safety and effectiveness of NNR06 Multi-Purpose Solution cleaning and disinfecting solution (Test) compared to COMPLETE Multi-Purpose Solution cleaning and disinfecting solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately three months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2015
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.
May 31, 2015
Actual (reported)July 27, 2015
Actual (reported)October 31, 2015
Actual (reported)October 31, 2015
Actual (reported)March 8, 2016
Actual (reported)May 31, 2017
Actual (reported)The Primary Safety Endpoint Was Statistical Non-inferiority With Respect to the Proportion of Eyes With Any Slit Lamp Findings Greater Than Grade 2 at Any Visit Between the Test and Control Solutions.
A non-inferiority upper bound of 0.05 (5%) was used to assess the difference (Test - Control) in proportions of slit lamp outcomes. Graded slit lamp findings for each eye were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding).
3 months
B \& L investigational NNR06 used as a rub care regimen (Test)
B\&L Multi-Purpose Solution as a rub care regimen (Control)
a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
Kannarr EyeCare
Pittsburg, Kansas, 66762, United States
Johnson Varughese
Valeant Pharmaceutcals NA
396 participants (actual enrollment reported by the registry).
First Submitted
July 27, 2015
First Posted
March 8, 2016
Study Start
May 31, 2015
Actual (reported)Vistakon Investigational Multi-purpose Contact Lens Care Solution.
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
October 31, 2015
Actual (reported)Study Completion
October 31, 2015
Actual (reported)Last Updated
February 8, 2022
Results First Posted
May 31, 2017
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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