Evaluation of Reflex Tear Production

January 21, 2025 updated by: Alcon Research
The purpose of this study is to evaluate reflex tear production following cotton swab nasal stimulation in subjects with dry eye disease (DED).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Cotton Swab Nasal Stimulation
Nostril probing for the purpose of producing reflex tearing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in TMH immediately following stimulation
Time Frame: 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.
Day 1 pre-stimulation (Baseline); Day 1 immediately post-stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Trial Lead, Pharma, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2024

Primary Completion (Actual)

November 7, 2024

Study Completion (Actual)

November 7, 2024

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEF512-E004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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