drugset / Trial / NCT06146881

Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia

NCT06146881

RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2022-10-02
Primary completion
2023-12-15
Completion
2024-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Diquafosol Oligonucleotide (other) 3 %
Comparator Sodium Hyaluronate Other / unclassified 0.1 %

Indications