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Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control

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ClinicalTrials.gov Identifier: NCT03325673
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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 TrueTear sham control (intranasal application which is not electrically active) in symptomatic CL wearers.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: TrueTear Device: TrueTear Sham Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-arm, Controlled Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control (CORIANDER)
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Tears

Arm Intervention/treatment
Experimental: TrueTear
TrueTear Device should be used intranasally on contact lens (CL) wear days; it may also be used on non-CL wear days if participant chooses. The number of applications is determined by participant.
Device: TrueTear
TrueTear Device should be used intranasally on contact lens (CL) wear days; it may also be used on non-CL wear days if participant chooses. The number of applications is determined by participant.

Placebo Comparator: TrueTear Sham Control
TrueTear sham device, which is not electrically active, should be used intranasally on contact lens (CL) wear days; it may also be used on non-CL wear days if participant chooses. The number of applications is determined by participant.
Device: TrueTear Sham Control
TrueTear sham device, which is not electrically active, should be used intranasally on contact lens (CL) wear days; it may also be used on non-CL wear days if participant chooses. The number of applications is determined by participant.




Primary Outcome Measures :
  1. Difference in contact lens comfortable wear time as determined by subject reported response on subjective rating scales [ Time Frame: Day 0 to Day 28 (±3 days) ]
    Difference in contact lens comfortable wear time in the analysis eye between the intranasal and sham control applications. Comfort will be assessed on a 100 point scale with a score of 0 indicating "Extremely uncomfortable" and a score of 100 indicating "Extremely comfortable".



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325673


Contacts
Contact: Clinical Trial Registry Team 877-277-8566 IR-CTRegistration@allergan.com

Locations
Canada, Ontario
Centre for Contact Lens Research School of Optometry & Vision Science, University of Waterloo Recruiting
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Allergan
Investigators
Study Director: Lyndon Jones, PhD lwjones@uwaterloo.ca

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03325673     History of Changes
Other Study ID Numbers: OCUN-024
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases