The Indonesian Research on Survey and Treatment for Dry Eye Disease (ThIRST DED): Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% to prevent dry eye disease in patient who will undergo cataract surgery. The main questions it aims to answer are: * The percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery. * The differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively. * The tear osmolarity and matix metalloproteinase-9 (MMP-9) after the treatment. * The difference in visual quality improvement assessed from higher order aberrations (HOA) and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%. Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery, and will be: * Interviewed regarding their identity, history of illness, and symptoms of dry eye disease. * Examined by researchers: eye condition, contrast sensitivity using the Pelli-Robson diagram, keratograph, HOA, tear osmolarity, MMP-9, corneal sensitivity, tear break up time (TBUT) , fluorescein break up pattern (FBUP). This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Cataract patients who will undergo phacoemulsification procedures and intraocular lens (IOL) implants

• Patients with dry eye disease

• Patients are willing to participate in the study and fill out informed consent

Locations
Other Locations
Indonesia
RSUPN Dr. Cipto Mangunkusumo
RECRUITING
Jakarta Pusat
Contact Information
Primary
Natasya Claudia Santoso
thristded@gmail.com
+6282132348778
Time Frame
Start Date: 2022-10-02
Estimated Completion Date: 2024-03-15
Participants
Target number of participants: 70
Treatments
Experimental: Diquafosol sodium 3% group
Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
Active_comparator: Sodium hyaluronate 0.1% group
Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
Related Therapeutic Areas
Sponsors
Leads: Indonesia University
Collaborators: Santen Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov