Dry Eye
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 years or above; 2. The presence of at least one subjective symptom such as dryness, foreign body sensation, burning sensation, sensation of fatigue, discomfort and vision fluctuation; 3. BUT <= 10s or Schirmer I test (no surface anesthesia) <= 10mm/5min; 4. Cornea fluorescein staining (CFS) is positive; 5. No administration of 3% diquafosol sodium eye drops within one week before enrollment; 6. Patients who are willing to sign the informed consent form (ICF) and complete the visits.
Exclusion criteria
Exclusion criteria: 1. Patients with either eye in legal blindness; 2. Patients with a history of allergies to any of the components of the drug or test reagent that is expected to be used in the study (e.g. diquafosol sodium and fluorescein); 3. Patients who need to receive topical or systemic non-steroidal anti-inflammatory drugs, steroid or immunosuppressant, or physiotherapy or ocular surgery with impact on dry eye, within 2 weeks before enrollment or during the study; 4. Patients who need to wear the contact lens within 2 weeks before enrollment or during the study; 5. Patients who ever received lacrimal punctum embolization, lacrimal punctum blocking, etc. which block puncta lacrimalia; 6. Patients who suffer from active eye disease besides dry eye; 7. Female patients who plan to be pregnant, are in the pregnancy or lactation period; 8. Patients who participated in within one month or are participating in other clinical trial; 9. Patients who are judged ineligible for this study by investigator due to non-controlled systematic diseases or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal Fluorescein Staining; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breakup time;Schirmer I test;Dry Eye related Quality of life Score;Corneal Fluorescein Staining; | — |
Countries
China
Contacts
Beijing Tongren Hospital, CMU