Immediate Therapeutic Effects of Diquafosol and Rebamipide in Dry Eye Disease

NCT07297316 | Completed Phase 4

• 1 other identifier: 2022AN0535
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• tear MUC1 concentration

  Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

• tear MUC5AC concentration

  Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

Study Arms (2)

R) DQS, L) REB

OTHER

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)

R) REB, L) DQS

OTHER

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)

Interventions

3% diquafosol (right eye) and 2% rebamipide (left eye) DRUG

3% diquafosol was instilled in the right eye and 2% rebamipide in the left eye.

R) DQS, L) REB

2% rebamipide (right eye) and 3% diquafosol (left eye) DRUG

2% rebamipide was instilled in the right eye and 3% diquafosol in the left eye.

R) REB, L) DQS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Kukje Pharma: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

diquafosol; rebamipide

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a paired-eye design study, where patients received 3% diquafosol in one eye and 2% rebamipide in the contralateral eye.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: October 3, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)