Dry Eye Disease (DED)Phase 4NCT07397936
Rebamipide Versus Diquafosol and Cyclosporine for Perioperative Dry Eye in Cataract Surgery
A Phase 4 study testing Rebamipide 2% ophthalmic solution, Diquafosol 3% ophthalmic solution and Cyclosporine 0.05% ophthalmic solution in people with Dry Eye Disease (DED) and Cataract, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. 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, Diquafosol 3% ophthalmic solution and Cyclosporine 0.05% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2025to 1 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Dry Eye Disease (DED), Cataract
- Being tested
- Rebamipide 2% ophthalmic solution, Diquafosol 3% ophthalmic solution, Cyclosporine 0.05% 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, four times daily
Diquafosol 3% ophthalmic solutionDrug
Topical administration, four times daily
Cyclosporine 0.05% ophthalmic solutionDrug
Topical administration, two times daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Diquafosol 3% ophthalmic solution; Drug: Cyclosporine 0.05% 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 and during the early postoperative period following cataract surgery, comparing rebamipide monotherapy with diquafosol-cyclosporine combination therapy.
Measured: From baseline to postoperative week 1
Secondary outcomes (4)
Change in Ocular Surface Disease Index (OSDI) Score
Change in patient-reported ocular symptoms assessed using the Ocular Surface Disease Index (OSDI) questionnaire, comparing rebamipide monotherapy with diquafosol-cyclosporine combination therapy. The OSDI score ranges from 0 to 100, with higher scores indicating more severe ocular surface symptoms (worse outcomes).
Measured: From baseline to 1 and 3 months postoperatively
Change in Corneal Staining Grade (Oxford Scale)
Change in corneal epithelial staining graded using the Oxford grading scale (0-5) following fluorescein staining, comparing ocular surface staining severity between treatment groups. Higher grades indicate more severe corneal epithelial staining (worse outcomes).
Measured: From baseline to postoperative week 1, and to 1 and 3 months postoperatively
Change in Schirmer's Test Value
Change in tear secretion measured by Schirmer's test without anesthesia, comparing tear production between rebamipide monotherapy and diquafosol-cyclosporine combination therapy.
Measured: From baseline to 1 and 3 months postoperatively
Change in Tear Matrix Metalloproteinase-9 (MMP-9) Level
Change in tear matrix metalloproteinase-9 (MMP-9) levels assessed using a point-of-care immunoassay (InflammaDry), comparing ocular surface inflammation between treatment groups.
Measured: From baseline to 1 and 3 months postoperatively
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 start1 Aug 2025
- Primary completion1 May 2026
- Study completion1 May 2026
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
- None (open label)
- Enrolment
- 56 participants (actual)
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
- NCT07397936
- Sponsor's protocol ID
- NRF-2021R1C1C1007795
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 27 Oct 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebamipide Versus Diquafosol-Cyclosporine for Perioperative Dry Eye Disease in Cataract Surgery: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07397936
- Acronym / sponsor ID
- NRF-2021R1C1C1007795
- Conditions
- Dry Eye Disease (DED), Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R | Experimental | Drug: Rebamipide 2% ophthalmic solutionParticipants receive topical rebamipide 2% ophthalmic solution four times daily, initiated 1 month before cataract surgery and continued for 3 months postoperatively. |
| Group DC | Active comparator | Drug: Diquafosol 3% ophthalmic solution, Drug: Cyclosporine 0.05% ophthalmic solutionParticipants 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. |
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 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:
- Ability and willingness to comply with the study protocol and follow-up schedule
- Provision of written informed consent
Key exclusion criteria (4 listed)
- 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
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, four times daily | Drug | Group R |
| Diquafosol 3% ophthalmic solutionTopical administration, four times daily | Drug | Group DC |
| Cyclosporine 0.05% ophthalmic solutionTopical administration, two times daily | Drug | Group DC |
Primary outcome
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.
4 secondary outcomes
Change in Ocular Surface Disease Index (OSDI) Score
Time frame: 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 Schirmer's Test Value
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, Diquafosol 3% ophthalmic solution and Cyclosporine 0.05% 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: finished, as of the sponsor's last update on 27 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 week 1). 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 27 Oct 2026.