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

NCT07397936 | Completed Phase 4

• 1 other identifier: NRF-2021R1C1C1007795
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease (DED); Cataract

Outcome Measures

Primary Outcomes (1)

• Change in Tear Film Breakup Time (TBUT)

  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 Outcomes (4)

• Change in Ocular Surface Disease Index (OSDI) Score

  From baseline to 1 and 3 months postoperatively

• Change in Corneal Staining Grade (Oxford Scale)

  From baseline to postoperative week 1, and to 1 and 3 months postoperatively

• Change in Schirmer's Test Value

  From baseline to 1 and 3 months postoperatively

• Change in Tear Matrix Metalloproteinase-9 (MMP-9) Level

  From baseline to 1 and 3 months postoperatively

Study Arms (2)

Group R

EXPERIMENTAL

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

Group DC

ACTIVE COMPARATOR

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; Drug: Cyclosporine 0.05% ophthalmic solution

Interventions

Diquafosol 3% ophthalmic solution DRUG

Topical administration, four times daily

Group DC

Cyclosporine 0.05% ophthalmic solution DRUG

Topical administration, two times daily

Group DC

Rebamipide 2% ophthalmic solution DRUG

Topical administration, four times daily

Group R

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract

Interventions

rebamipide; Ophthalmic Solutions; diquafosol; Cyclosporine

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)