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Real world study for 3% diquafosol ophthalmic solution in dry eye patients

Real world study for 3% diquafosol ophthalmic solution in dry eye patients

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052852
Enrollment
Unknown
Registered
2021-11-06
Start date
2021-11-03
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

DQS(diquafosol ophthalmic solution) treatment group:No

Sponsors

Xiamen Eye Center of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with dry eye; 2. Patients who are prescribed to use 3% diquafosol ophthalmic solution by physicians; 3. Patients joined the study voluntarily and has signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. 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); 2. Administration of 3% diquafosol sodium eye drops within two weeks before enrollment; 3. Patients who need to receive adjustment in topical treatment due to other reasons except for dry eye within observation period; 4. Patients who have participated in other clinical trial within one month before the study or those who are participating in other clinical trial simultaneously; 5. Patients who are judged ineligible for this study by investigator due to non-controlled systematic diseases or other reasons.

Design outcomes

Primary

MeasureTime frame
Change in FBUT(fluorescein tear film break-up time) from baseline;

Secondary

MeasureTime frame
Change in DEQS (dry eye questionnaire score) from baseline;Change in FBUT from baseline;Change in lid margin abnormal score from baseline ;Change in lipid layer thickness (only conduct in appointed sites) from baseline;Change in tear meniscus height (only conduct in appointed sites) from baseline;Change in meibomian gland examination result (only conduct in appointed sites) from baseline;Change in CFS (corneal fluorescein staining) score from baseline;Change in Schirmer I test from baseline;The percentage of patients who continue treatment;

Countries

China

Contacts

Public ContactWang Wei

Santen Pharmaceutical (China) Co., Ltd.

wei.wang2@santen.com+86 15210821977

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026