Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

TrueTear™ Application

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ocular Technology Group International

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

TrueTear™ Intranasal then Extranasal Application

TrueTear™ Extranasal then Intranasal Application

Arm Description

TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 14.

TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 14.

Outcomes

Primary Outcome Measures

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.

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 .

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03274999

First Posted

September 5, 2017

Last Updated

March 4, 2021

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT03274999

Brief Title

Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

Based on interim review and decision to re-design the study.

Study Start Date

October 18, 2017 (Actual)

Primary Completion Date

November 9, 2017 (Actual)

Study Completion Date

November 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allergan

4. Oversight

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

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TrueTear™ Intranasal then Extranasal Application

Arm Type

Experimental

Arm Description

TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 14.

Arm Title

TrueTear™ Extranasal then Intranasal Application

Arm Type

Experimental

Arm Description

TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 14.

Intervention Type

Device

Intervention Name(s)

TrueTear™ Application

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink

Description

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.

Time Frame