Rebamipide Versus Diquafosol for Perioperative Dry Eye in Cataract Surgery

Sponsor
Samsung Medical Center
Study ID
NCT07397949
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Cataract
  • Dry Eye Disease (DED)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rebamipide 2% ophthalmic solution — DRUG
    Topical administration to the surgical eye, four times daily.
  • Diquafosol 3% ophthalmic solution — DRUG
    Topical administration to the surgical eye, four times daily.

Study Details

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.

Key Dates

First listed
Feb 9, 2026
Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rebamipide Group
    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.
  • Active Comparator: Diquafosol Group
    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.

Primary Outcome Measure

Change in Tear Film Breakup Time (TBUT) [ Time Frame: From baseline to postoperative 1 month ]

Central Contacts

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