Status:
COMPLETED
Sphenopalatine Ganglion Stimulation for Ocular and Oral Dryness
Lead Sponsor:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Conditions:
Dry Eye Disease
Xerostomia
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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...
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 pharm...
Eligibility Criteria
Inclusion
- \> 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.
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
January 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05187533
Start Date
January 15 2022
End Date
October 30 2024
Last Update
November 1 2024
Active Locations (1)
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1
IOBA
Valladolid, Valladolid, Spain, 47011