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

NCT03325673 | Completed Results FDA Device

• 1 other identifier: OCUN-024
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

TrueTear

EXPERIMENTAL

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.

Device: TrueTear

TrueTear Sham Control

SHAM COMPARATOR

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.

Device: TrueTear Sham Control

Interventions

TrueTear DEVICE

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

TrueTear Sham Control DEVICE

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 Control

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Centre for Contact Lens Research School of Optometry & Vision Science, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Michelle Senchyna

  Allergan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 30, 2017
• Study Start: November 22, 2017
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: December 18, 2019
• Results First Posted: December 6, 2019

Record last verified: 2019-12

Locations

CA (1)