Immediate Therapeutic Effects of Diquafosol and Rebamipide in Dry Eye Disease

NCT ID: NCT07297316

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2024-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Disease (DED)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

This is a paired-eye design study, where patients received 3% diquafosol in one eye and 2% rebamipide in the contralateral eye.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

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

Intervention Type DRUG

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

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.

Group Type OTHER

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

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kukje Pharma

OTHER

Sponsor Role collaborator

Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dong Hyun Kim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022AN0535

Identifier Type: -

Identifier Source: org_study_id