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

Allergan

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Device: TrueTear Sham Control; Device: TrueTear

Study type: Interventional

Funder types: Industry

Identifiers

NCT03325673

OCUN-024

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A person is eligible for inclusion if he/she

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups

TrueTear

Experimental group

Description:

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.

Treatment:

Device: TrueTear

TrueTear Sham Control

Sham Comparator group

Description:

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.

Treatment:

Device: TrueTear Sham Control