Status:
COMPLETED
Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control
Lead Sponsor:
Allergan
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
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 T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2018
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03325673
Start Date
November 22 2017
End Date
November 29 2018
Last Update
December 18 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre for Contact Lens Research School of Optometry & Vision Science, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1