Stimulation Therapy to Produce Tears for the Treatment of Dry Eye

Phase 1

Completed

• Conditions: Dry eye disease; Eye - Diseases / disorders of the eye; Eye - Normal eye development and function

• Registration Number: ACTRN12613001075774
• Lead Sponsor: Oculeve, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Willing to sign the informed consent and deemed capable of following the study protocol

Basal Schirmer tear test of less than or equal to 15 mm; Schirmer test at least twice or at least 10 mm higher after nasal stimulation with cotton swab

Baseline Ocular Surface Disease Index score of at least 13

Normal lid anatomy, blinking function and closure

Corrected visual acuity of 20/200 (Snellen equivalent) or better in each eye

Exclusion Criteria

Individuals with a history or presence of any systemic disorder or condition that is not stabilized or would likely interfere with the interpretation of study results or subject safety

Presence of severe systemic allergy or acute or chronic rhinitis or sinusitis

Individuals with the presence or history of any ocular disorder or condition that would likely interfere with the interpretation of study results or subject safety

Nasal, orbital or lacrimal trauma, surgery, tumour or cancer

Significant corneal or conjunctival scarring of any aetiology

Known hypersensitivity to one of the components of the study device or procedural medications

Patients with a history of chronic or recurrent epistaxis

Participation in any clinical trial with a new active substance or a new device during the past 3 months

Women who are pregnant, planning a pregnancy or nursing at study entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Schirmer test score compared to baseline[At 6 months after start of study treatment];Adverse events - Possible adverse events can include headache, pain/discomfort, and nosebleed, all assessed through case history.[At 6 months after start of study treatment]

Secondary Outcome Measures

Name	Time	Method
Mean Ocular Surface Disease Index score compared to baseline[At 6 months after start of study treatment ];Mean dry eye symptoms as assessed by a Visual Analogue Scale compared to baseline[At 6 months after start of study treatment]