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COMPLETED
NCT07397936
PHASE4

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

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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.

Official title: Rebamipide Versus Diquafosol-Cyclosporine for Perioperative Dry Eye Disease in Cataract Surgery: A Randomized Trial

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-08-01

Completion Date

2026-05-01

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

Rebamipide 2% ophthalmic solution

Topical administration, four times daily

DRUG

Diquafosol 3% ophthalmic solution

Topical administration, four times daily

DRUG

Cyclosporine 0.05% ophthalmic solution

Topical administration, two times daily

Locations (1)

Samsung Medical Center

Seoul, Seoul, South Korea