Randomized, Double-arm, Controlled Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control (CORIANDER)
Sponsor study identifier
interventional
84
1 country
1
Study Start
November 22, 2017
Actual (reported)Primary Completion
November 29, 2018
Actual (reported)Study Completion
November 29, 2018
Actual (reported)This study will evaluate the increase in comfort and comfortable contact lens (CL) wear time associated with application of TrueTear (active intranasal neurostimulation) compared with application of TrueTear sham control (intranasal application which is not electrically active) in symptomatic CL wearers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 29, 2018
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 3, 2017
Actual (reported)October 30, 2017
Actual (reported)November 22, 2017
Actual (reported)November 29, 2018
Actual (reported)November 29, 2018
Actual (reported)December 6, 2019
Actual (reported)Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye
The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst). The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
Day 28
Comfort Rating Score in the Study Eye
The participant assessed contact lens comfort in the study eye using a 100 point scale where a score of 0=Extremely uncomfortable and a score of 100=Extremely comfortable. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
CL Insertion, After 2 hours and the End of Day on Day 24
Comfortable Wear Time (CWT) in the Study Eye
CWT was calculated by taking the difference between the time participants reported started to find their CLs getting uncomfortable and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
Day 24
Total Wear Time (Total WT) in the Study Eye
Total WT was calculated by taking the difference between the time participants reported removing their CLs and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
Day 24
TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on contact lens (CL) wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
TrueTear sham device, which is not electrically active and has limited tip insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
TrueTear sham device, which is not electrically active and has limited tip insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
Centre for Contact Lens Research School of Optometry & Vision Science, University of Waterloo
Waterloo, Ontario, N2L 3G1, Canada
Michelle Senchyna
Allergan
84 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2017
First Posted
October 30, 2017
Study Start
November 22, 2017
Actual (reported)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
November 29, 2018
Actual (reported)Study Completion
November 29, 2018
Actual (reported)Last Updated
December 18, 2019
Results First Posted
December 6, 2019
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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