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Effectiveness and Safety of 3% Diquafosol Sodium Eye Drops in Patients with Dry Eye

Effectiveness and Safety of 3% Diquafosol Sodium Eye Drops in Patients with Dry Eye

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021999
Enrollment
Unknown
Registered
2019-03-19
Start date
2019-03-15
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Interventions

Case series:3% DQS eye drops

Sponsors

Beijing Tongren Hospital, CMU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
Corneal Fluorescein Staining;

Secondary

MeasureTime frame
Breakup time;Schirmer I test;Dry Eye related Quality of life Score;Corneal Fluorescein Staining;

Countries

China

Contacts

Public ContactZhiqing Pan

Beijing Tongren Hospital, CMU

781385283@qq.com+86 13911799840

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026