Rebamipide Versus Diquafosol for Perioperative Dry Eye in Cataract Surgery

NCT07397949 | Not Yet Recruiting Phase 4

• 1 other identifier: RVK-25-I01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is designed to compare two commonly used eye drop treatments for dry eye disease in patients undergoing cataract surgery. Dry eye disease is common in people who need cataract surgery and may worsen before or after surgery, causing eye discomfort, blurred vision, and unstable vision. Proper management of dry eye before and after surgery may help improve eye comfort and the accuracy of vision outcomes. In this study, patients with mild to moderate dry eye disease who are scheduled for cataract surgery will be randomly assigned to receive one of two treatments: Rebamipide eye drops, or Diquafosol eye drops Participants will begin using the assigned eye drops one month before cataract surgery and continue treatment for three months after surgery. The eye drops will be used only in the eye undergoing surgery. Researchers will examine whether one treatment is as effective as the other in improving tear film stability and reducing dry eye symptoms around the time of cataract surgery. Eye examinations and questionnaires will be performed before surgery, on the day of surgery, and during follow-up visits after surgery. The information gained from this study may help doctors choose the most appropriate treatment for managing dry eye disease in patients undergoing cataract surgery.

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 to the postoperative period, comparing rebamipide and diquafosol for perioperative management of dry eye disease in patients undergoing cataract surgery.

  From baseline to postoperative 1 month

Secondary Outcomes (4)

• Change in Ocular Surface Disease Index (OSDI) Score

  From baseline to postoperative 1 and 3 months

• Change in Corneal Staining Grade (Oxford Scale)

  From baseline to postoperative 1 month

• Change in Schirmer's Test Value

  From baseline to postoperative 1 and 3 months

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

  From baseline to postoperative 1 and 3 months

Study Arms (2)

Rebamipide Group

EXPERIMENTAL

Participants receive topical rebamipide 2% ophthalmic solution administered four times daily to the surgical eye, starting 1 month before cataract surgery and continuing for 3 months postoperatively.

Drug: Rebamipide 2% ophthalmic solution

Diquafosol Group

ACTIVE COMPARATOR

Participants receive topical diquafosol 3% ophthalmic solution administered four times daily to the surgical eye, starting 1 month before cataract surgery and continuing for 3 months postoperatively.

Drug: Diquafosol 3% ophthalmic solution

Interventions

Rebamipide 2% ophthalmic solution DRUG

Topical administration to the surgical eye, four times daily.

Rebamipide Group

Diquafosol 3% ophthalmic solution DRUG

Topical administration to the surgical eye, four times daily.

Diquafosol Group

Eligibility Criteria

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

You may qualify if:

• Adults aged 40 years or older scheduled for unilateral cataract surgery
• Presence of dry eye disease, defined by 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 minutes
• Ability and willingness to comply with the study protocol and follow-up schedule
• Provision of written informed consent

You may not qualify if:

• Active ocular infection or inflammation, including infectious keratitis
• History of ocular surgery other than cataract surgery in the study eye
• Use of topical medications that may affect the ocular surface (e.g., intraocular pressure-lowering eye drops)
• Any ocular or systemic condition judged by the investigator to interfere with study participation or outcome assessment

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Mec

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract

Interventions

rebamipide; Ophthalmic Solutions; diquafosol

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

Central Study Contacts

Dong-Hui Lim, MD, PhD

CONTACT

+82 2-3410-5478; ldhlse@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• 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: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)