NCT06146881

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

Status unknown Phase 2 Last updated 27 November 2023

What this trial tests

Phase 2 trial testing Diquafosol sodium 3% in Dry Eye Disease in 70 participants. Status unknown.

Timeline

2 October 2022

Primary endpoint
15 December 2023

15 March 2024

Quick facts

Lead sponsor	Indonesia University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	70
Start date	2 October 2022
Primary completion	15 December 2023
Estimated completion	15 March 2024
Sites	1 location across Indonesia

Drugs / interventions tested

• Diquafosol sodium 3% — full drug profile →
• Sodium hyaluronate 0.1% — full drug profile →

Conditions studied

• Dry Eye Disease — all drugs for Dry Eye Disease →

Sponsor

Indonesia University

Who can join

Eligibility, any sex, with Dry Eye Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.