Table 1

Eligibility criteria

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).

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

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.

  • DED, dry eye disease.