Dry Eye DiseaseNCT05187533
Sphenopalatine Ganglion Stimulation for Ocular and Oral Dryness
A study testing Osteopathic protocol of Sphenopalatine Ganglion Stimulation in people with Dry Eye Disease and Xerostomia, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
Trial summary
Dry Eye Disease (DED) is a multifactorial pathology characterized by inflammation of the lacrimal functional unit that develops in ocular surface pathology, severely affecting patients quality of life. The core of the treatment relies at present in antinflammatory topical therapies, which are still scarce. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dry Eye Disease, Xerostomia
- What is being tested?
- Osteopathic protocol of Sphenopalatine Ganglion Stimulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2022to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old.
- Patients diagnosed with Dry eye disease (DED) and suffering symptoms of ocular and oral dryness for at least 6 months.
- "Dry eye" symptoms must have a score of > 2 (0-4 range) in mSIDEQ questionnaire.
- Ocularly symptomatic patients (OSDI > 12) despite the medication, medical devices and/or therapeutic measures carried out until the inclusion.
- Symptomatic patients in terms of oral dryness (XI-Sp > 11) despite the medication, medical devices and/or therapeutic measures carried out until the inclusion.
- Schirmer I test, without topical anesthesia, must have an initial value of ≥ 1 mm and <10 mm.
- Not included in any other clinical pharmacological trial or study (medical devices are excluded) in the last 3 months.
- Signed informed consent and ability to complete all study visits.
Who cannot join
- Irreversible anatomical alteration of the lacrimal glands (watery, sebaceous or mucinic) or salivary, surgeries or by healing processes that affect eyelids and/or conjunctiva.
- Alteration in the autonomic nervous system.
- Another active ocular surface disease different from that caused by DED.
- Oral diseases, inflammations or acute injuries in the mouth (trauma, surgical intervention, etc.) in the last month or healing processes of the oral mucosa.
- Use of cyclosporine or topical tacrolimus started within < 3 months and/or steroids or blood derivatives started within < 1 month and that will not be maintained during the study.
- Use of orally drugs with exocrine hyposecretory side effects or that may affect the parasympathetic nervous system, unless the dose is stable during the previous month to inclusion and whose dose is not expected to vary throughout this study.
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- Patients may be using any other medication, topical or systemic, unless the dose are the same for the duration of the study.
- Patients may be using artificial tears, moisturizers in general or blood derivatives, unless the dose was the same in the last month and has to be maintained at the same dose for the duration of the study.
- To have had any "in-office" method to manage DED or Meibomian gland dysfunction (pulsed light, thermal massages, etc.) in the last 6 months.
- Occlusion of the lacrimal puncta in the last month.
- Local (in cranial sphere) or general anesthesia in the last 3 months.
- Use of contact lenses, unless they stop using them for at least one week before inclusion and one week before each visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Sphenopalatine Ganglion Stimulation Osteopathic Protocol in Patients with Ocular and Oral Dryness
Dry Eye Disease (DED) is a multifactorial pathology characterized by inflammation of the lacrimal functional unit that develops in ocular surface pathology, severely affecting patients quality of life. The core of the treatment relies at present in antinflammatory topical therapies, which are still scarce.
The investigators hypothesize that osteopathy-based techniques may help these patients by influencing the central involvement regarding parasympathetic innervation of tear and saliva-secreting glands.
Read more
The aim of this osteopathic treatment protocol is to release the involved structures in the tear-secreting system innervation, such as the sphenopalatine ganglion. In addition, this ganglion innervates the minor salivary glands, therefore it is intended to help patients suffering from xerostomia.
The hypothesis then is that a systemic protocol treatment can help balance both parts of the vegetative nervous system (sympathetic and parasympathetic) with the objective of increasing the secretion of tear and saliva in patients with ocular and oral dryness (DED and xerostomia, respectively), thus improving their clinical situation.
This osteopathic protocol does not have the potential to cause adverse effects. The main objective is to analyze the efficacy of this protocol application in terms of improving symptoms and signs of ocular and oral dryness, tear film quality and inflammation molecule levels in tears and saliva.
Read the detailed description
This clinical study intended to offer an alternative therapeutic tool for a disease, dry eye, that is highly prevalent, causes a decreased in the quality of life and work productivity, and whose pharmacologic treatment is very limited.
The osteopathy protocol consists of an initial assessment of the cranial vault and 7 techniques through which the different structures involved are treated and are as follows: 1) balance of the cranio-sacral system; 2) reharmonization of sphenobasilar synchondrosis; 3) and 4) release of the bony components in the pterygo-palatine fossa (maxillas and sphenoid); 5) and 6) release of the bony components in relation with the main lacrimal gland (frontal and front-malar suture); and 7) sphenopalatine ganglion stimulation. The patient is always in supine position and the investigator is standing on the side.
The proposed osteopathy protocol is innocuous, with no possible adverse effects. The main objective is to analyze the efficacy of this protocol application in terms of improving symptoms and signs of ocular and oral dryness, tear film quality and inflammation molecule levels in tears and saliva.
Recruited patients will have dry eye disease (and subsequently ocular dryness) and oral dryness (xerostomia). Inclusion/exclusion criteria are detailed in the corresponding section below, as well as all outcome measures.
All COVID19-related sanitary regulations will be strictly followed.
- Conditions
- Dry Eye Disease, Xerostomia
- Being tested
- Osteopathic protocol of Sphenopalatine Ganglion Stimulation
- Keywords
- dry eye disease, dryness, osteopathy, Keratoconjunctivitis sicca, Saliva cytokines, Saliva-producing glands, Sjögren´s syndrome, Sphenopalatine ganglion, Tear-producing glands, Tear cytokines, Tear film, Xerostomia
- Medical subject headings
- Dry Eye Syndromes, Xerostomia, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic protocol of Sphenopalatine Ganglion StimulationOther
Sphenopalatine Ganglion Stimulation to improve lacrimal and salivary gland secretion to improve ocular and oral dryness
| Study group | Role | What they receive |
|---|---|---|
| Mild dry eye disease | Other | Osteopathic protocol of sphenopalatine ganglion stimulation Receives: Other: Osteopathic protocol of Sphenopalatine Ganglion Stimulation |
| Moderate dry eye disease | Other | Osteopathic protocol of sphenopalatine ganglion stimulation Receives: Other: Osteopathic protocol of Sphenopalatine Ganglion Stimulation |
| Severe dry eye disease | Other | Osteopathic protocol of sphenopalatine ganglion stimulation Receives: Other: Osteopathic protocol of Sphenopalatine Ganglion Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI)
Score value 0-48, where higher score means a worse outcome.
Measured: 6 Weeks
Ocular Surface Disease Index (OSDI)
Score value 0-48, where higher score means a worse outcome.
Measured: 18 Weeks
Modified Single-Item Score Dry Eye-Questionnaire (mSIDEQ)
Score value 0-28, where higher score means a worse outcome
Measured: 6 Weeks
Modified Single-Item Score Dry Eye-Questionnaire (mSIDEQ)
Score value 0-28, where higher score means a worse outcome
Measured: 18 Weeks
Visual analogue Scale (VAS)
Unique measurements 0-10, where higher score means a worse outcome
Measured: 6 Weeks
Visual analogue Scale (VAS)
Unique measurements 0-10, where higher score means a worse outcome
Measured: 18 Weeks
Change in Dry Eye Symptoms Questionnaire (CDES-Q)
First question compares how the patient is at the moment compared with last session in terms of "Equal", "Better" or "Worse". If better or worse is chose, two more questions measure how much improvement or worsening from a 0-10 scale, where higher score means a worse outcome.
Measured: 6 Weeks
Change in Dry Eye Symptoms Questionnaire (CDES-Q)
First question compares how the patient is at the moment compared with last session in terms of "Equal", "Better" or "Worse". If better or worse is chose, two more questions measure how much improvement or worsening from a 0-10 scale, where higher score means a worse outcome.
Measured: 18 Weeks
Statistically significant amelioration in oral symptoms
Enhancement in Xerostomia Inventory Spanish version (XI-Sp) test score 0-11, where higher score means a worse outcome.
Measured: 6 Weeks
Statistically significant amelioration in oral symptoms
Enhancement in Xerostomia Inventory Spanish version (XI-Sp) test score 0-11, where higher score means a worse outcome.
Measured: 18 Weeks
Statistically significant improvement in tear secretion
Schirmer I test, which test score is 0-35 mm, where lower score means a worse outcome.
Measured: 6 Weeks
Statistically significant improvement in tear secretion
Schirmer I test, which test score is 0-35 mm, where lower score means a worse outcome.
Measured: 18 Weeks
Statistically significant improvement in salivary discharge
Salivary flow rate, where flow rate below 0,1ml flow is considered hyposalivation.
Measured: 6 Weeks
Statistically significant improvement in salivary discharge
Salivary flow rate, where flow rate below 0,1ml flow is considered hyposalivation.
Measured: 18 Weeks
Secondary outcomes (8)
Decrease in tear collection time
Statistically significant improvement in tear collection time, using a microcapillar of 1μl.
Measured: 18 Weeks
Increased salivary flow rate
Statistically significant increased salivary flow rate, using Modified Fox Sreebny Technique.
Measured: 18 Weeks
Lipiflow interferometry - lipid layer thickness
Statistically significant improvement in lipid layer thickness using Interferometry with Lipiview.
Measured: 18 Weeks
Lipiflow interferometry - incomplete blink rate
Statistically significant improvement in incomplete blink rate using Interferometry with Lipiview.
Measured: 18 Weeks
Lipiflow interferometry - c-factor
Statistically significant improvement in c-factor, using Interferometry with Lipiview.
Measured: 18 Weeks
Enhancement in Break-Up Time Test
Statistically significant enhancement in Break-Up Time Test (normal >7 seconds) where lower score means a worse outcome.
Measured: 18 Weeks
Corneal Staining
Statistically significant enhancement in Corneal Staining, using Oxford Scale and Cornea and Contact Lens Research Unit (CCLRU) Scale, score 0-5 where higher scores means worse outcome.
Measured: 18 Weeks
Significant beneficial change in molecules evaluated in tear or saliva
The following putative salivary indicators of pain are assayed by enzyme-linked immunosorbent assay (ELISA): Cortisol (DRG Salivary Cortisol ELISA (DRG Instruments GmbH, Marburg, Germany), testosterone (DRG Instruments GmbH), sTNFαRII (Quantikine, Human sTNF RII/TNFRSF1B Immunoassay, R\&D Systems, Minneapolis, MN, USA). sAA is
Measured: 18 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start15 Jan 2022
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187533
- Sponsor's protocol ID
- IOBA-2021-23
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2021
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Sphenopalatine Ganglion Stimulation Osteopathic Protocol in Patients with Ocular and Oral Dryness
- ClinicalTrials.gov ID
- NCT05187533
- Acronym / sponsor ID
- IOBA-2021-23
- Conditions
- Dry Eye Disease, Xerostomia
- Keywords
- dry eye disease, dryness, osteopathy, Keratoconjunctivitis sicca, Saliva cytokines, Saliva-producing glands, Sjögren´s syndrome, Sphenopalatine ganglion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 12 Jan 2022 (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.
Dry Eye Disease (DED) is a multifactorial pathology characterized by inflammation of the lacrimal functional unit that develops in ocular surface pathology, severely affecting patients quality of life. The core of the treatment relies at present in antinflammatory topical therapies, which are still scarce.
The investigators hypothesize that osteopathy-based techniques may help these patients by influencing the central involvement regarding parasympathetic innervation of tear and saliva-secreting glands.
The aim of this osteopathic treatment protocol is to release the involved structures in the tear-secreting system innervation, such as the sphenopalatine ganglion. In addition, this ganglion innervates the minor salivary glands, therefore it is intended to help patients suffering from xerostomia.
The hypothesis then is that a systemic protocol treatment can help balance both parts of the vegetative nervous system (sympathetic and parasympathetic) with the objective of increasing the secretion of tear and saliva in patients with ocular and oral dryness (DED and xerostomia, respectively), thus improving their clinical situation.
This osteopathic protocol does not have the potential to cause adverse effects. The main objective is to analyze the efficacy of this protocol application in terms of improving symptoms and signs of ocular and oral dryness, tear film quality and inflammation molecule levels in tears and saliva.
Detailed description
This clinical study intended to offer an alternative therapeutic tool for a disease, dry eye, that is highly prevalent, causes a decreased in the quality of life and work productivity, and whose pharmacologic treatment is very limited.
The osteopathy protocol consists of an initial assessment of the cranial vault and 7 techniques through which the different structures involved are treated and are as follows: 1) balance of the cranio-sacral system; 2) reharmonization of sphenobasilar synchondrosis; 3) and 4) release of the bony components in the pterygo-palatine fossa (maxillas and sphenoid); 5) and 6) release of the bony components in relation with the main lacrimal gland (frontal and front-malar suture); and 7) sphenopalatine ganglion stimulation. The patient is always in supine position and the investigator is standing on the side.
The proposed osteopathy protocol is innocuous, with no possible adverse effects. The main objective is to analyze the efficacy of this protocol application in terms of improving symptoms and signs of ocular and oral dryness, tear film quality and inflammation molecule levels in tears and saliva.
Recruited patients will have dry eye disease (and subsequently ocular dryness) and oral dryness (xerostomia). Inclusion/exclusion criteria are detailed in the corresponding section below, as well as all outcome measures.
All COVID19-related sanitary regulations will be strictly followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild dry eye disease | Other | Other: Osteopathic protocol of Sphenopalatine Ganglion StimulationOsteopathic protocol of sphenopalatine ganglion stimulation |
| Moderate dry eye disease | Other | Other: Osteopathic protocol of Sphenopalatine Ganglion StimulationOsteopathic protocol of sphenopalatine ganglion stimulation |
| Severe dry eye disease | Other | Other: Osteopathic protocol of Sphenopalatine Ganglion StimulationOsteopathic protocol of sphenopalatine ganglion stimulation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- > 18 years old.
- Patients diagnosed with Dry eye disease (DED) and suffering symptoms of ocular and oral dryness for at least 6 months.
- "Dry eye" symptoms must have a score of > 2 (0-4 range) in mSIDEQ questionnaire.
- Ocularly symptomatic patients (OSDI > 12) despite the medication, medical devices and/or therapeutic measures carried out until the inclusion.
- Symptomatic patients in terms of oral dryness (XI-Sp > 11) despite the medication, medical devices and/or therapeutic measures carried out until the inclusion.
Key exclusion criteria (12 listed)
- Irreversible anatomical alteration of the lacrimal glands (watery, sebaceous or mucinic) or salivary, surgeries or by healing processes that affect eyelids and/or conjunctiva.
- Alteration in the autonomic nervous system.
- Another active ocular surface disease different from that caused by DED.
- Oral diseases, inflammations or acute injuries in the mouth (trauma, surgical intervention, etc.) in the last month or healing processes of the oral mucosa.
- Use of cyclosporine or topical tacrolimus started within < 3 months and/or steroids or blood derivatives started within < 1 month and that will not be maintained during the study.
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 |
|---|---|---|
| Osteopathic protocol of Sphenopalatine Ganglion StimulationSphenopalatine Ganglion Stimulation to improve lacrimal and salivary gland secretion to improve ocular and oral dryness | Other | Mild dry eye disease, Moderate dry eye disease, Severe dry eye disease |
Primary outcome
Ocular Surface Disease Index (OSDI)
Time frame: 6 Weeks
Score value 0-48, where higher score means a worse outcome.
Ocular Surface Disease Index (OSDI)
Time frame: 18 Weeks
Score value 0-48, where higher score means a worse outcome.
Modified Single-Item Score Dry Eye-Questionnaire (mSIDEQ)
Time frame: 6 Weeks
Score value 0-28, where higher score means a worse outcome
Modified Single-Item Score Dry Eye-Questionnaire (mSIDEQ)
Time frame: 18 Weeks
Score value 0-28, where higher score means a worse outcome
Visual analogue Scale (VAS)
Time frame: 6 Weeks
Unique measurements 0-10, where higher score means a worse outcome
Visual analogue Scale (VAS)
Time frame: 18 Weeks
Unique measurements 0-10, where higher score means a worse outcome
Change in Dry Eye Symptoms Questionnaire (CDES-Q)
Time frame: 6 Weeks
First question compares how the patient is at the moment compared with last session in terms of "Equal", "Better" or "Worse". If better or worse is chose, two more questions measure how much improvement or worsening from a 0-10 scale, where higher score means a worse outcome.
Change in Dry Eye Symptoms Questionnaire (CDES-Q)
Time frame: 18 Weeks
First question compares how the patient is at the moment compared with last session in terms of "Equal", "Better" or "Worse". If better or worse is chose, two more questions measure how much improvement or worsening from a 0-10 scale, where higher score means a worse outcome.
Statistically significant amelioration in oral symptoms
Time frame: 6 Weeks
Enhancement in Xerostomia Inventory Spanish version (XI-Sp) test score 0-11, where higher score means a worse outcome.
Statistically significant amelioration in oral symptoms
Time frame: 18 Weeks
Enhancement in Xerostomia Inventory Spanish version (XI-Sp) test score 0-11, where higher score means a worse outcome.
Statistically significant improvement in tear secretion
Time frame: 6 Weeks
Schirmer I test, which test score is 0-35 mm, where lower score means a worse outcome.
Statistically significant improvement in tear secretion
Time frame: 18 Weeks
Schirmer I test, which test score is 0-35 mm, where lower score means a worse outcome.
Statistically significant improvement in salivary discharge
Time frame: 6 Weeks
Salivary flow rate, where flow rate below 0,1ml flow is considered hyposalivation.
Statistically significant improvement in salivary discharge
Time frame: 18 Weeks
Salivary flow rate, where flow rate below 0,1ml flow is considered hyposalivation.
8 secondary outcomes
Decrease in tear collection time
Time frame: 18 Weeks
Increased salivary flow rate
Time frame: 18 Weeks
Lipiflow interferometry - lipid layer thickness
Time frame: 18 Weeks
Lipiflow interferometry - incomplete blink rate
Time frame: 18 Weeks
Lipiflow interferometry - c-factor
Time frame: 18 Weeks
Enhancement in Break-Up Time Test
Time frame: 18 Weeks
Corneal Staining
Time frame: 18 Weeks
Significant beneficial change in molecules evaluated in tear or saliva
Time frame: 18 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No
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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 Osteopathic protocol of Sphenopalatine Ganglion Stimulation in people with Dry Eye Disease and Xerostomia, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
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 8 inclusion and 12 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: finished, as of the sponsor's last update on 1 Nov 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ocular Surface Disease Index (OSDI) (time frame: 6 Weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2024.