Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

Allergan

Status: Terminated

Conditions: Dry Eye Syndromes

Treatments: Device: TrueTear™ Application

Study type: Interventional

Funder types: Industry

Identifiers

NCT03274999

OCUN-020

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

TrueTear™ Intranasal then Extranasal Application

Experimental group

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.

Treatment:

Device: TrueTear™ Application

TrueTear™ Extranasal then Intranasal Application

Experimental group

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.

Treatment:

Device: TrueTear™ Application