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

To Evaluate the Efficacy of Diquafosol Sodium in the Treatment of MGD in Different Treatment Pattern | DecenTrialz