| Inclusion criteria | 1. Patients with diagnosis of DED with or without Sjögren's syndrome, refractory to conventional treatment. 2. Male or female patients. 3. ≥18 years of age. 4. Schirmer 1 test (with anaesthesia) of <5 mm/5 min in at least one eye 5. Mild superficial punctate keratitis (fluorescein staining score of >3 out of 15 in either eye) 6. One or more dry-eye symptoms (dryness, burning, photophobia, tearing, ocular fatigue, and foreign body sensation).
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| Exclusion criteria | 1. Patients with one blind eye. 2. Patients with visual acuity of 20/40 or worse in one without a justifiable cause. 3. Patients with history of active stage of any other concomitant ocular disease 4. Patients taking any medication, topically or by any other route, which could interfere with the study's results, in the 3 days prior to trial, or until a time period in which residual effects could be present. 5. History of hypersensitivity or any medical condition that contraindicates the use of the study drug or any of its compounds, or derivatives 6. Contact lens users. 7. Fertile-age women with an inadequate birth-control method, as well as pregnant or breastfeeding women. 8. Legally disqualified or mentally disabled patients who cannot sign an informed consent 9. Patients who cannot comply with medical appointments or with all protocol requirements. 10. Patients who disagree to participate in the trial. 11. Patients with any other ocular disorder: ocular injury, infection, non-dry eye ocular inflammation, trauma, or surgery within the previous 6 months11
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| Deletion criteria | 1. Patients who miss their follow-up appointments. 2. Patients who do not apply medication as prescribed 3. Patients who voluntarily leave the trial.
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