Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT05187533
Eligibility Criteria:
Inclusion Criteria:
* \> 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05187533
Study Brief:
Protocol Section:
NCT05187533