Dry Eye Disease (DED)Phase 4NCT07297316
Immediate Therapeutic Effects of Diquafosol and Rebamipide in Dry Eye Disease
A Phase 4 study testing 3% diquafosol (right eye) and 2% rebamipide (left eye) and 2% rebamipide (right eye) and 3% diquafosol (left eye) in people with Dry Eye Disease (DED), run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
This study compares the immediate therapeutic and mucin-secreting effects 30 minutes after instillation of 3% diquafosol and 2% rebamipide in dry eye disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- 3% diquafosol (right eye) and 2% rebamipide (left eye) and 2% rebamipide (right eye) and 3% diquafosol (left eye)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Oct 2022to 30 Aug 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients 19 years or older
- complaint of at least one dry eye symmptom and tear breakup time < 7 seconds
Who cannot join
- Sjogren's syndrome
- prescription history of systemic steroids or immunosuppressants
- prior ocular surgery within six months of enrollment
- treatment with diquafosol or rebamipide eye drops within 2 weeks of enrollment
- treatment with punctal plug within 1 month of enrollment
- intraocular pressure exceeding 25mmHg
Show all 9Show fewer
- usage of contact lens during the study
- active ocular infection
- pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Immediate Therapeutic Effects of 3% Diquafosol and 2% Rebamipide in Dry Eye Disease
This study compares the immediate therapeutic and mucin-secreting effects 30 minutes after instillation of 3% diquafosol and 2% rebamipide in dry eye disease.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- 3% diquafosol (right eye) and 2% rebamipide (left eye), 2% rebamipide (right eye) and 3% diquafosol (left eye)
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% diquafosol (right eye) and 2% rebamipide (left eye)Drug
3% diquafosol was instilled in the right eye and 2% rebamipide in the left eye.
2% rebamipide (right eye) and 3% diquafosol (left eye)Drug
2% rebamipide was instilled in the right eye and 3% diquafosol in the left eye.
| Study group | Role | What they receive |
|---|---|---|
| R) DQS, L) REB | Other | This is a paired-eye design study. Patients were randomly assigned to receive 3% diquafosol in the right eye and 2% rebamipide in the contralateral left eye, with the treatment assignment blinded to the examiner and patients. Receives: Drug: 3% diquafosol (right eye) and 2% rebamipide (left eye) |
| R) REB, L) DQS | Other | This is a paired-eye design study. Patients were randomly assigned to receive 3% diquafosol in the left eye and 2% rebamipide in the contralateral right eye, with the treatment assignment blinded to the examiner and patients. Receives: Drug: 2% rebamipide (right eye) and 3% diquafosol (left eye) |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS) score
Unit: points
Measured: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
tear breakup time (TBUT)
Unit: Seconds
Measured: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
ocular staining score (OSS)
National Eye Institute Scale, 0-15
Measured: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
tear meniscus height (TMH)
Unit: mm
Measured: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
lipid layer thickenss (LLT)
Unit: nm
Measured: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
corneal sensitivity (esthesiometer)
Unit: mm
Measured: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Secondary outcomes (2)
tear MUC1 concentration
measured using enzyme-linked immunosorbent assay (ELISA)
Measured: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
tear MUC5AC concentration
measured using enzyme-linked immunosorbent assay (ELISA)
Measured: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start3 Oct 2022
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
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.
- 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
- Single group
- Model description
- This is a paired-eye design study, where patients received 3% diquafosol in one eye and 2% rebamipide in the contralateral eye.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kukje Pharma
- Responsible party
- Principal investigator, Dong Hyun Kim, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297316
- Sponsor's protocol ID
- 2022AN0535
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are not openly available due to reasons of sensitivity and may available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immediate Therapeutic Effects of 3% Diquafosol and 2% Rebamipide in Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07297316
- Acronym / sponsor ID
- 2022AN0535
- Conditions
- Dry Eye Disease (DED)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Kukje Pharma
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 22 Dec 2025 (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 study compares the immediate therapeutic and mucin-secreting effects 30 minutes after instillation of 3% diquafosol and 2% rebamipide in dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a paired-eye design study, where patients received 3% diquafosol in one eye and 2% rebamipide in the contralateral eye.
| Arm | Type | Receives |
|---|---|---|
| R) DQS, L) REB | Other | Drug: 3% diquafosol (right eye) and 2% rebamipide (left eye)This is a paired-eye design study. Patients were randomly assigned to receive 3% diquafosol in the right eye and 2% rebamipide in the contralateral left eye, with the treatment assignment blinded to the examiner and patients. |
| R) REB, L) DQS | Other | Drug: 2% rebamipide (right eye) and 3% diquafosol (left eye)This is a paired-eye design study. Patients were randomly assigned to receive 3% diquafosol in the left eye and 2% rebamipide in the contralateral right eye, with the treatment assignment blinded to the examiner and patients. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients 19 years or older
- complaint of at least one dry eye symmptom and tear breakup time < 7 seconds
Key exclusion criteria (9 listed)
- Sjogren's syndrome
- prescription history of systemic steroids or immunosuppressants
- prior ocular surgery within six months of enrollment
- treatment with diquafosol or rebamipide eye drops within 2 weeks of enrollment
- treatment with punctal plug within 1 month of enrollment
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 |
|---|---|---|
| 3% diquafosol (right eye) and 2% rebamipide (left eye)3% diquafosol was instilled in the right eye and 2% rebamipide in the left eye. | Drug | R) DQS, L) REB |
| 2% rebamipide (right eye) and 3% diquafosol (left eye)2% rebamipide was instilled in the right eye and 3% diquafosol in the left eye. | Drug | R) REB, L) DQS |
Primary outcome
visual analog scale (VAS) score
Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Unit: points
tear breakup time (TBUT)
Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Unit: Seconds
ocular staining score (OSS)
Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
National Eye Institute Scale, 0-15
tear meniscus height (TMH)
Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Unit: mm
lipid layer thickenss (LLT)
Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Unit: nm
corneal sensitivity (esthesiometer)
Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Unit: mm
2 secondary outcomes
tear MUC1 concentration
Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
tear MUC5AC concentration
Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
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 22 Dec 2025.
- Individual participant dataSharing planned: No. The data that support the findings of this study are not openly available due to reasons of sensitivity and may 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 3% diquafosol (right eye) and 2% rebamipide (left eye) and 2% rebamipide (right eye) and 3% diquafosol (left eye) in people with Dry Eye Disease (DED), run by Korea University Anam Hospital 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 2 inclusion and 9 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 22 Dec 2025. 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?
visual analog scale (VAS) score (time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops). The study lists 6 primary outcomes in all. 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 22 Dec 2025.