Increased Production of TearsNCT07632183
Will a Hands on Technique Applied to the Face Increase the Tear Production in Participants
A study testing sphenopalatine ganglion release in people with Increased Production of Tears, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
Trial summary
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?… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Increased Production of Tears
- What is being tested?
- sphenopalatine ganglion release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-45
- 1st- 4th year medical students, faculty and staff volunteers at specific College of Osteopathic medicine campus
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VCOM- Carolinas Campus
Spartanburg, South Carolina, 29303
About this study
Official title: 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
Read the 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
- Conditions
- Increased Production of Tears
- Being tested
- sphenopalatine ganglion release
- Keywords
- Osteopathic Manipulative Medicine, Osteopathic Manipulative Technique, tear production, sphenopalatine ganglion, sphenopalatine ganglion release
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sphenopalatine ganglion releaseProcedure or surgery
Employs the technique of sphenopalatine ganglion release through use of manual manipulation with a gloved finger intraorally
| Study group | Role | What they receive |
|---|---|---|
| Population with no history of dry eye | Experimental | Pilot that will have participants with no history of dry eye participate to see if there is an increase in tear production Receives: Procedure: sphenopalatine ganglion release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer measurements on Participants
Will measure tear production via the Schirmer test strips and will compare pre and post intervention
Measured: From enrollment to the end of treatment at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start8 Oct 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Increased Production of TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632183
- Sponsor's protocol ID
- 2024-155
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stevens S. Schirmer's test. Community Eye Health. 2011 Dec;24(76):45. No abstract available.
PubMed 22389568Sherman T, Qureshi Y, Bach A. Osteopathic Manipulative Treatment to Manage Ophthalmic Conditions. J Am Osteopath Assoc. 2017 Sep 1;117(9):568-575. doi: 10.7556/jaoa.2017.111.
PubMed 28846123
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment of the Sphenopalatine Ganglion for Induction of Lacrimation: A Pilot Study
- ClinicalTrials.gov ID
- NCT07632183
- Acronym / sponsor ID
- 2024-155
- Conditions
- Increased Production of Tears
- Keywords
- Osteopathic Manipulative Medicine, Osteopathic Manipulative Technique, tear production, sphenopalatine ganglion, sphenopalatine ganglion release
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population with no history of dry eye | Experimental | Procedure: sphenopalatine ganglion releasePilot that will have participants with no history of dry eye participate to see if there is an increase in tear production |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18-45
- 1st- 4th year medical students, faculty and staff volunteers at specific College of Osteopathic medicine campus
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sphenopalatine ganglion releaseEmploys the technique of sphenopalatine ganglion release through use of manual manipulation with a gloved finger intraorally | Procedure or surgery | Population with no history of dry eye |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Results publication: PubMed 22389568Stevens S. Schirmer's test. Community Eye Health. 2011 Dec;24(76):45. No abstract available.
- Results publication: PubMed 28846123Sherman T, Qureshi Y, Bach A. Osteopathic Manipulative Treatment to Manage Ophthalmic Conditions. J Am Osteopath Assoc. 2017 Sep 1;117(9):568-575. doi: 10.7556/jaoa.2017.111.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sphenopalatine ganglion release in people with Increased Production of Tears, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer measurements on Participants (time frame: From enrollment to the end of treatment at 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07632183, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.