Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

Dry Eye Syndromes Clinical Trial

Official title:

Randomized, Controlled, Single-Center, Cross-Over Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03274999
• Other study ID #: OCUN-020
• Status: Terminated
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: November 9, 2017

Study information

• Verified date: March 2021
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the change in tear meniscus height (TMH) produced by intranasal stimulation with TrueTear™ compared with the same device applied extranasally (control).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 9, 2017
• Est. primary completion date: November 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Baseline Ocular Surface Disease Index© (OSDI©) score of at least 23 with no more than three responses of "not applicable"

• In at least one eye, a baseline Schirmer test of = 10 mm/5 minutes AND a cotton swab nasal stimulation Schirmer test of at least 7 mm higher in the same eye

Exclusion Criteria:

• 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

• Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit

• Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head

Related Conditions & MeSH terms

• Dry Eye Syndromes

Intervention

Device:
• TrueTear™ Application
Intranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14.

Locations

Country	Name	City	State
United Kingdom	Ocular Technology Group International	London

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink	Tear meniscus height is defined as the mean height of the lower tear prism to the edge of the eye lid measured by the investigator using the Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to time (T) T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 minutes (mins) after application was reported. A negative change from Baseline (Pre-application) indicates improvement.	Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Primary	Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink	Lipid layer thickness is defined as the average thickness of the lipid layer calculated from the thickness of the various pattern weighted by the relative coverage of each pattern measured by the investigator using the Tearscope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. A negative change from Baseline (Pre-application) indicates improvement .	Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Primary	Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)	Non-invasive break-up time is the time in seconds between eye opening and the appearance of the first visible break in the lipid layer of the pre-corneal tear film measured by the investigator using the Tearscope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. A negative change from Baseline (Pre-application) indicates improvement.	Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Primary	Change From Pre-application in Protective Index (PI)	The Protected Index (PI) corresponds to the percentage of the corneal surface that is not exposed to the atmosphere (i.e. fully covered by the tear film) over the full interblink period measured by the investigator using a Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported.	Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Primary	Change From Pre-application in Exposed Area (EA)	Exposed Area is defined as the percentage of the observed area not covered by the tear film at the time of the blink hence exposed to the atmosphere measured by the investigator using a Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported.	Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application

External Links

•   For information to locate a study location near you, please visit AllerganClinicalTrials.com