Dry Eye Disease (DED)Phase 4NCT07397949
Rebamipide Versus Diquafosol for Perioperative Dry Eye in Cataract Surgery
A Phase 4 study testing Rebamipide 2% ophthalmic solution and Diquafosol 3% ophthalmic solution in people with Dry Eye Disease (DED) and Cataract, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Dry Eye Disease (DED), Cataract
- What is being tested?
- Rebamipide 2% ophthalmic solution and Diquafosol 3% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2026to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Mec
Seoul, Seoul
Dong-Hui Lim, +82 2 3410 5478, ldhlse@gmail.com
About this study
Official title: A Randomized Noninferiority Trial Comparing Rebamipide and Diquafosol for Perioperative Dry Eye Management in Cataract Surgery
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.
Read more
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.
Read the detailed description
Dry eye disease (DED) is frequently observed in patients undergoing cataract surgery and may be exacerbated by surgical trauma, postoperative inflammation, and disruption of corneal innervation. Worsening of dry eye symptoms during the perioperative period can negatively affect patient comfort, tear film stability, and visual outcomes after surgery. Therefore, effective perioperative management of dry eye disease is an important component of cataract surgery care.
This study is a prospective, randomized, parallel-group, investigator-initiated clinical trial designed to compare the efficacy of rebamipide 2% ophthalmic solution and diquafosol 3% ophthalmic solution for perioperative management of dry eye disease in patients undergoing cataract surgery.
Eligible adult patients with mild to moderate dry eye disease who are scheduled for unilateral cataract surgery will be randomly assigned in a 1:1 ratio to one of two treatment groups. Participants will receive either rebamipide or diquafosol eye drops administered to the surgical eye, starting one month before cataract surgery and continuing for three months postoperatively. Standard postoperative medications for cataract surgery will be administered according to routine clinical practice.
The primary outcome measure is the change in tear film breakup time (TBUT) from baseline to the postoperative period. Secondary outcome measures include changes in corneal staining grade, patient-reported symptoms assessed using the Ocular Surface Disease Index (OSDI), tear secretion measured by Schirmer's test, ocular surface inflammation assessed by tear matrix metalloproteinase-9 (MMP-9), corneal topography, optical biometry parameters, meibomian gland function, and patient-reported discomfort related to eye drop use.
Clinical assessments will be conducted at baseline, on the day of surgery, and at postoperative follow-up visits according to the study schedule. Safety will be monitored throughout the study by assessing adverse events and ocular findings at each visit.
This study aims to determine whether rebamipide is non-inferior to diquafosol in maintaining tear film stability and improving dry eye symptoms during the perioperative period of cataract surgery, thereby providing evidence to guide optimal dry eye management strategies in this patient population.
- Conditions
- Dry Eye Disease (DED), Cataract
- Being tested
- Rebamipide 2% ophthalmic solution, Diquafosol 3% ophthalmic solution
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebamipide 2% ophthalmic solutionDrug
Topical administration to the surgical eye, four times daily.
Diquafosol 3% ophthalmic solutionDrug
Topical administration to the surgical eye, four times daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Diquafosol 3% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to postoperative 1 month
Secondary outcomes (4)
Change in Ocular Surface Disease Index (OSDI) Score
Change in patient-reported dry eye symptoms assessed using the Ocular Surface Disease Index (OSDI) questionnaire.
Measured: From baseline to postoperative 1 and 3 months
Change in Corneal Staining Grade (Oxford Scale)
Change in corneal epithelial staining graded using the Oxford scale following fluorescein staining.
Measured: From baseline to postoperative 1 month
Change in Schirmer's Test Value
Change in tear secretion measured by Schirmer's test without anesthesia.
Measured: From baseline to postoperative 1 and 3 months
Change in Tear Matrix Metalloproteinase-9 (MMP-9) Level
Change in tear matrix metalloproteinase-9 (MMP-9) levels assessed using a commercially available tear MMP-9 test.
Measured: From baseline to postoperative 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Hui Lim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397949
- Sponsor's protocol ID
- RVK-25-I01
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The detailed study protocol and the data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Noninferiority Trial Comparing Rebamipide and Diquafosol for Perioperative Dry Eye Management in Cataract Surgery
- ClinicalTrials.gov ID
- NCT07397949
- Acronym / sponsor ID
- RVK-25-I01
- Conditions
- Dry Eye Disease (DED), Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dry eye disease (DED) is frequently observed in patients undergoing cataract surgery and may be exacerbated by surgical trauma, postoperative inflammation, and disruption of corneal innervation. Worsening of dry eye symptoms during the perioperative period can negatively affect patient comfort, tear film stability, and visual outcomes after surgery. Therefore, effective perioperative management of dry eye disease is an important component of cataract surgery care.
This study is a prospective, randomized, parallel-group, investigator-initiated clinical trial designed to compare the efficacy of rebamipide 2% ophthalmic solution and diquafosol 3% ophthalmic solution for perioperative management of dry eye disease in patients undergoing cataract surgery.
Eligible adult patients with mild to moderate dry eye disease who are scheduled for unilateral cataract surgery will be randomly assigned in a 1:1 ratio to one of two treatment groups. Participants will receive either rebamipide or diquafosol eye drops administered to the surgical eye, starting one month before cataract surgery and continuing for three months postoperatively. Standard postoperative medications for cataract surgery will be administered according to routine clinical practice.
The primary outcome measure is the change in tear film breakup time (TBUT) from baseline to the postoperative period. Secondary outcome measures include changes in corneal staining grade, patient-reported symptoms assessed using the Ocular Surface Disease Index (OSDI), tear secretion measured by Schirmer's test, ocular surface inflammation assessed by tear matrix metalloproteinase-9 (MMP-9), corneal topography, optical biometry parameters, meibomian gland function, and patient-reported discomfort related to eye drop use.
Clinical assessments will be conducted at baseline, on the day of surgery, and at postoperative follow-up visits according to the study schedule. Safety will be monitored throughout the study by assessing adverse events and ocular findings at each visit.
This study aims to determine whether rebamipide is non-inferior to diquafosol in maintaining tear film stability and improving dry eye symptoms during the perioperative period of cataract surgery, thereby providing evidence to guide optimal dry eye management strategies in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebamipide Group | Experimental | Drug: Rebamipide 2% ophthalmic solutionParticipants 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. |
| Diquafosol Group | Active comparator | Drug: Diquafosol 3% ophthalmic solutionParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Ability and willingness to comply with the study protocol and follow-up schedule
- Provision of written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebamipide 2% ophthalmic solutionTopical administration to the surgical eye, four times daily. | Drug | Rebamipide Group |
| Diquafosol 3% ophthalmic solutionTopical administration to the surgical eye, four times daily. | Drug | Diquafosol Group |
Primary outcome
Change in Tear Film Breakup Time (TBUT)
Time frame: From baseline to postoperative 1 month
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.
4 secondary outcomes
Change in Ocular Surface Disease Index (OSDI) Score
Time frame: From baseline to postoperative 1 and 3 months
Change in Corneal Staining Grade (Oxford Scale)
Time frame: From baseline to postoperative 1 month
Change in Schirmer's Test Value
Time frame: From baseline to postoperative 1 and 3 months
Change in Tear Matrix Metalloproteinase-9 (MMP-9) Level
Time frame: From baseline to postoperative 1 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No. The detailed study protocol and the data that support the findings of this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rebamipide 2% ophthalmic solution and Diquafosol 3% ophthalmic solution in people with Dry Eye Disease (DED) and Cataract, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-Hui Lim, MD, PhD (+82 2-3410-5478, ldhlse@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tear Film Breakup Time (TBUT) (time frame: From baseline to postoperative 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.