Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-18

Study Completion Date

2017-11-09

Brief Summary

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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).

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TrueTear™ Intranasal then Extranasal Application

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.

Group Type EXPERIMENTAL

TrueTear™ Application

Intervention Type DEVICE

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

TrueTear™ Extranasal then Intranasal Application

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.

Group Type EXPERIMENTAL

TrueTear™ Application

Intervention Type DEVICE

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

Interventions

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TrueTear™ Application

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No