Immediate Therapeutic Effects of Diquafosol and Rebamipide in Dry Eye Disease

Comparison of Immediate Therapeutic Effects of 3% Diquafosol and 2% Rebamipide in Dry Eye Disease

This study compares the immediate therapeutic and mucin-secreting effects 30 minutes after instillation of 3% diquafosol and 2% rebamipide in dry eye disease.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: 3% diquafosol (right eye) and 2% rebamipide (left eye); Drug: 2% rebamipide (right eye) and 3% diquafosol (left eye)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients 19 years or older
• complaint of at least one dry eye symmptom and tear breakup time < 7 seconds

Exclusion Criteria:

• Sjogren's syndrome
• prescription history of systemic steroids or immunosuppressants
• prior ocular surgery within six months of enrollment
• treatment with diquafosol or rebamipide eye drops within 2 weeks of enrollment
• treatment with punctal plug within 1 month of enrollment
• intraocular pressure exceeding 25mmHg
• usage of contact lens during the study
• active ocular infection
• pregnancy or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: R) DQS, L) REB; This is a paired-eye design study. Patients were randomly assigned to receive 3% diquafosol in the right eye and 2% rebamipide in the contralateral left eye, with the treatment assignment blinded to the examiner and patients.	Drug: 3% diquafosol (right eye) and 2% rebamipide (left eye); 3% diquafosol was instilled in the right eye and 2% rebamipide in the left eye.
Other: R) REB, L) DQS; This is a paired-eye design study. Patients were randomly assigned to receive 3% diquafosol in the left eye and 2% rebamipide in the contralateral right eye, with the treatment assignment blinded to the examiner and patients.	Drug: 2% rebamipide (right eye) and 3% diquafosol (left eye); 2% rebamipide was instilled in the right eye and 3% diquafosol in the left eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale (VAS) score	Unit: points	Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
tear breakup time (TBUT)	Unit: Seconds	Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
ocular staining score (OSS)	National Eye Institute Scale, 0-15	Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
tear meniscus height (TMH)	Unit: mm	Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
lipid layer thickenss (LLT)	Unit: nm	Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
corneal sensitivity (esthesiometer)	Unit: mm	Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tear MUC1 concentration	measured using enzyme-linked immunosorbent assay (ELISA)	Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
tear MUC5AC concentration	measured using enzyme-linked immunosorbent assay (ELISA)	Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Collaborators: Kukje Pharma

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; rebamipide; diquafosol
• Other Study ID Numbers: 2022AN0535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that support the findings of this study are not openly available due to reasons of sensitivity and may available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No