Evaluation of Reflex Tear Production

Not Applicable

Terminated

• Conditions: Dry Eye Disease
• Interventions: Procedure: Cotton Swab Nasal Stimulation

• Registration Number: NCT06565624
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate reflex tear production following cotton swab nasal stimulation in subjects with dry eye disease (DED).

Detailed Description

The primary analysis will assess the change from baseline (pre- versus immediately post-cotton swab nasal stimulation) in tear meniscus height (TMH) using optical coherence tomography (OCT). This study will consist of one visit on a single day.

Study Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-22
• Study Start: 2024-10-17
• Primary Completion: 2024-11-07
• Study Completion: 2024-11-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

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

Inclusion Criteria

• Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported.
• Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms.
• Corrected Visual Acuity (Snellen) 20/200 or better in both eyes.
• Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history.
• Able, as assessed by the investigator, and willing to follow study instructions.
• Other protocol-specified inclusion criteria may apply.

Key

Exclusion Criteria

• Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration).
• Use of artificial tears within 2 hours of the Study Visit.
• History of ocular surgery within 1 year of the Study Visit.
• Use of contact lenses in either eye within 7 days of the Study Visit.
• Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit.
• Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nasal Stimulation	Cotton Swab Nasal Stimulation	The Investigator will insert cotton swabs into both nostrils of the subject and gently probe the nasal middle cavities. Stimulation will stop once visible and obvious reflex tearing has begun.

Primary Outcome Measures

Name	Time	Method
Change from baseline in TMH immediately following stimulation	Day 1 pre-stimulation (Baseline); Day 1 immediately post-stimulation	TMH (the distance between the line of reflection along the top of the tear prism to the edges of the eyelids) will be measured in millimeters using OCT, a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. TMH will be assessed prior to nasal stimulation and upon completion of nasal stimulation. Only one eye will be assessed by OCT.

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States