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

NCT06146881 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-11-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Diquafosol sodium 3%

Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery

DRUG

Sodium hyaluronate 0.1%

Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery

Sponsors & Collaborators

  • Santen Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06146881 on ClinicalTrials.gov