Will a Hands on Technique Applied to the Face Increase the Tear Production in Participants

June 1, 2026 updated by: Edward Via Virginia College of Osteopathic Medicine

Osteopathic Manipulative Treatment of the Sphenopalatine Ganglion for Induction of Lacrimation: A Pilot Study

The goal of this interventional study is to learn if a hands on technique will increase tear production in patients aged 45 and younger, without a history of eye issues. The main question it aims to answer is:

Will there be an increase in tear production using a specific hand on technique applied inside the mouth?

Participants will have a small, sterile, piece of paper that will be placed briefly in their eye. This is done to take measurements of tear production. A doctor will then perform a hands on technique in which a gloved finger is placed in the participants' mouth to release the tension that is found. After the technique is completed, the participants' eye will be retested with the tear strip. The tear test strip will be applied twice more on the following visits at 2 days after the first session and one week after the first session

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as an experimental pilot study for proof of concept with pre- and post- test measurements taken on the same individual. We will be measuring at time points 0 (baseline), immediately after treatment (within 5 minutes), 2 day, and 1 week each with a standardized Schirmer's Test for tear production. This study is intended to gather data on around 30 individuals within the set inclusion/exclusion criteria.

The proposed mechanism is that stimulation of the parasympathetic nervous system via the sphenopalatine ganglion may induce increased lacrimation and provide relief (of yet unknown duration or efficacy) for patients who report sensations of dry eye

Study Type

Interventional

Enrollment (Estimated)

30

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
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • VCOM- Carolinas Campus

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age 18-45
  • 1st- 4th year medical students, faculty and staff volunteers at specific College of Osteopathic medicine campus

Exclusion Criteria:

  • volunteers who have had ophthalmologic surgery
  • diagnosis of dry eye syndrome
  • diagnosis of temporomandibular joint disease
  • individuals who are greater than 45 years of age.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Population with no history of dry eye
Pilot that will have participants with no history of dry eye participate to see if there is an increase in tear production
Procedure: sphenopalatine ganglion release
Employs the technique of sphenopalatine ganglion release through use of manual manipulation with a gloved finger intraorally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schirmer measurements on Participants
Time Frame: From enrollment to the end of treatment at 1 week
Will measure tear production via the Schirmer test strips and will compare pre and post intervention
From enrollment to the end of treatment at 1 week

Collaborators and Investigators

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

Sponsor

Edward Via Virginia College of Osteopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 8, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-155

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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