Evaluation of Reflex Tear Production

NCT06565624 | Terminated

• 1 other identifier: DEF512-E004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Dry Eye Disease

Keywords

Reflex Tear Production

Outcome Measures

Primary Outcomes (1)

• Change from baseline in TMH immediately following 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.

  Day 1 pre-stimulation (Baseline); Day 1 immediately post-stimulation

Study Arms (1)

Nasal Stimulation

EXPERIMENTAL

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.

Procedure: Cotton Swab Nasal Stimulation

Interventions

Cotton Swab Nasal Stimulation PROCEDURE

Nostril probing for the purpose of producing reflex tearing

Nasal Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Clinical Trial Lead, Pharma

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: October 17, 2024
• Primary Completion: November 7, 2024
• Study Completion: November 7, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)