drugset / Trial / NCT07397936

Rebamipide Versus Diquafosol and Cyclosporine for Perioperative Dry Eye in Cataract Surgery

NCT07397936

Phase 4 Completed 55 enrolled Samsung Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to compare the efficacy of 2% rebamipide monotherapy versus a combination therapy of 3% diquafosol and 0.05% cyclosporine for the management of dry eye disease in patients undergoing cataract surgery. It will also evaluate the safety and ocular surface stability effects of these treatments during the perioperative period. The main questions it aims to answer are: Does rebamipide monotherapy maintain tear film breakup time (TBUT) and prevent corneal damage as effectively as the combination therapy after surgery? How do patient symptoms (OSDI scores) and inflammation markers (MMP-9) change with each treatment? Researchers will compare the rebamipide group to the diquafosol-cyclosporine combination group to evaluate their effects on perioperative dry eye management. Participants will: Use the assigned study eye drops starting 1 month before their cataract surgery and continuing for 3 months after surgery. Visit the clinic for eye examinations at baseline, the day of surgery, and at 1 week, 1 month, and 3 months postoperatively. Undergo tests including tear film breakup time measurement, corneal staining, Schirmer's test, and tear MMP-9 level assessments.

Timeline

Start
2024-08-01
Primary completion
2025-05-01
Completion
2025-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide 0.05 % Topical
Comparator Diquafosol Oligonucleotide (other) 3 % Topical
Subject Rebamipide Small molecule 2 % Topical