- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03325673
Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control
December 16, 2019 updated by: Allergan
Randomized, Double-arm, Controlled Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control (CORIANDER)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Waterloo, Ontario, Canada, N2L 3G1
- Centre for Contact Lens Research School of Optometry & Vision Science, University of Waterloo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
A person is eligible for inclusion if he/she
- In at least one eye, has a cotton swab nasal stimulation Schirmer test score at least 4 mm greater than 3 minute Schirmer with anesthesia basal score in the same eye at the Screening Visit
- Is an adapted soft contact lens wearer and currently wears lenses an average of at least 2 days per week, with an average minimum wearing time of 3 hours each day over the past month and is able and willing to wear lenses for at least 6 hours on four study day visits
- Has at least 20/40 visual acuity in both eyes with CL correction
- Is symptomatic according to Young's categorization
Exclusion Criteria:
- Refractive error surgery
- Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding
- History of nasal or sinus surgery
- Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit
- Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TrueTear
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 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.
|
SHAM_COMPARATOR: TrueTear Sham Control
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye
Time Frame: Day 28
|
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
Time Frame: CL Insertion, After 2 hours and the End of Day on Day 24
|
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
Time Frame: Day 24
|
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
Time Frame: Day 24
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 22, 2017
Primary Completion (ACTUAL)
November 29, 2018
Study Completion (ACTUAL)
November 29, 2018
Study Registration Dates
First Submitted
October 3, 2017
First Submitted That Met QC Criteria
October 27, 2017
First Posted (ACTUAL)
October 30, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 18, 2019
Last Update Submitted That Met QC Criteria
December 16, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCUN-024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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