Status:
UNKNOWN
To Evaluate the Efficacy of Diquafosol Sodium in the Treatment of MGD in Different Treatment Pattern
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions:
Dry Eye
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
MGD is a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion. It may result in ...
Eligibility Criteria
Inclusion
- Patients with FBUT\<10s;
- Presence of ocular symptoms with OSDI score≥13;
- 0\<The score of meibum quality or expressibility ≤2;
- 1/3≤The meibomian drop-out ≤2/3 (meiboscore ≤2)
Exclusion
- patients diagnosed of dry eye with Sjogren syndrome or diabetic mellitus.
- Patients who wear contact lens during study or accepted refractive surgery within 6 months before screening.
- Patients who have allergy history or adverse reactions to the experimental drugs or its components.
- Patients with active ocular inflammation such as infectious keratitis or blepharitis.
- Patients who had received ocular or system steroids or immunosuppressant 2 weeks before screening.
- Patients who had received any other experimental drug 2 weeks before screening.
- Patients with concomitant disease who were considered unable to evaluate efficacy or unlikely to complete the expected course of treatment and follow-up.
- Pregnant and lactating women, or those planning a pregnancy over the course of the study.
- Patients judged by the investigator to be unsuitable for the study.
Key Trial Info
Start Date :
August 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05383612
Start Date
August 5 2022
End Date
May 20 2025
Last Update
February 21 2023
Active Locations (1)
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1
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080