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

February 2, 2026 updated by: Dong Hui Lim, Samsung Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dry eye disease (DED) is common in patients undergoing cataract surgery and may worsen during the perioperative period, leading to ocular discomfort and delayed visual recovery. Pharmacologic treatments targeting tear film instability and ocular surface inflammation are therefore important in perioperative management.

This prospective, randomized, parallel-group clinical trial compared two perioperative treatment strategies for DED in patients scheduled for cataract surgery. Eligible participants with pre-existing dry eye disease were randomized in a 1:1 ratio to receive either topical rebamipide 2% monotherapy or combination therapy with topical diquafosol 3% and cyclosporine 0.05%. Study medications were initiated 1 month prior to surgery and continued for 3 months postoperatively.

The primary outcome measure was the change in tear film breakup time (TBUT) during the early postoperative period. Secondary outcome measures included changes in corneal staining graded by the Oxford scale, patient-reported symptoms assessed by the Ocular Surface Disease Index (OSDI), tear secretion measured by Schirmer's test, and ocular surface inflammation evaluated using a tear matrix metalloproteinase-9 (MMP-9) point-of-care immunoassay.

Clinical assessments were performed at baseline, on the day of surgery, and at postoperative week 1, month 1, and month 3. Safety was evaluated by monitoring intraoperative and postoperative adverse events throughout the study period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults scheduled for cataract surgery

  • Presence of dry eye disease, defined as an Ocular Surface Disease Index (OSDI) score ≥12 and at least one of the following:

    • Tear film breakup time (TBUT) ≤7 seconds
    • Oxford corneal staining grade ≥1
    • Schirmer's test value ≤10 mm/5 min
  • Ability and willingness to comply with the study protocol and follow-up schedule
  • Provision of written informed consent

Exclusion Criteria:

  • Presence of ocular surface or ocular conditions that could affect dry eye status (e.g., active keratitis or ocular infection)
  • Use of topical intraocular pressure-lowering medications
  • History of ocular surgery other than cataract surgery in the study eye
  • Any systemic or ocular condition judged by the investigator to interfere with study participation or outcome assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group R
Participants receive topical rebamipide 2% ophthalmic solution four times daily, initiated 1 month before cataract surgery and continued for 3 months postoperatively.
Drug: Rebamipide 2% ophthalmic solution
Topical administration, four times daily
Active Comparator: Group DC
Participants receive topical diquafosol 3% ophthalmic solution four times daily in combination with cyclosporine 0.05% ophthalmic solution twice daily, initiated 1 month before cataract surgery and continued for 3 months postoperatively.
Drug: Diquafosol 3% ophthalmic solution
Topical administration, four times daily
Drug: Cyclosporine 0.05% ophthalmic solution
Topical administration, two times daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Tear Film Breakup Time (TBUT)
Time Frame: From baseline to postoperative week 1
Change in tear film breakup time (TBUT) from baseline and during the early postoperative period following cataract surgery, comparing rebamipide monotherapy with diquafosol-cyclosporine combination therapy.
From baseline to postoperative week 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Ocular Surface Disease Index (OSDI) Score
Time Frame: From baseline to 1 and 3 months postoperatively
Change in patient-reported ocular symptoms assessed using the Ocular Surface Disease Index (OSDI) questionnaire, comparing rebamipide monotherapy with diquafosol-cyclosporine combination therapy.
From baseline to 1 and 3 months postoperatively
Change in Corneal Staining Grade (Oxford Scale)
Time Frame: From baseline to postoperative week 1, and to 1 and 3 months postoperatively
Change in corneal epithelial staining graded using the Oxford grading scale following fluorescein staining, comparing ocular surface stability between treatment groups.
From baseline to postoperative week 1, and to 1 and 3 months postoperatively
Change in Schirmer's Test Value
Time Frame: From baseline to 1 and 3 months postoperatively
Change in tear secretion measured by Schirmer's test without anesthesia, comparing tear production between rebamipide monotherapy and diquafosol-cyclosporine combination therapy.
From baseline to 1 and 3 months postoperatively
Change in Tear Matrix Metalloproteinase-9 (MMP-9) Level
Time Frame: From baseline to 1 and 3 months postoperatively
Change in tear matrix metalloproteinase-9 (MMP-9) levels assessed using a point-of-care immunoassay (InflammaDry), comparing ocular surface inflammation between treatment groups.
From baseline to 1 and 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NRF-2021R1C1C1007795

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The detailed study protocol and the data that support the findings of this study are 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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