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CompletedNCT07297316Updated Dec 22, 2025

Immediate Therapeutic Effects of Diquafosol and Rebamipide in Dry Eye Disease

A Phase 4 interventional study of 3% diquafosol (right eye) and 2% rebamipide (left eye) and 2% rebamipide (right eye) and 3% diquafosol (left eye) in Dry Eye Disease (DED), sponsored by Korea University Anam Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by Korea University Anam Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Oct 2022, registered Dec 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dry Eye Disease (DED)

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03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Korea University Anam Hospital is the lead sponsor of 110 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients 19 years or older
  • complaint of at least one dry eye symmptom and tear breakup time \< 7 seconds

Exclusion criteria

Exclusion Criteria:

  • 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
  • usage of contact lens during the study
  • active ocular infection
  • pregnancy or breast-feeding
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Other
    R) DQS, L) REB

    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.

    Drug: 3% diquafosol (right eye) and 2% rebamipide (left eye)

  • Other
    R) REB, L) DQS

    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.

    Drug: 2% rebamipide (right eye) and 3% diquafosol (left eye)

Interventions

  • Drug3% diquafosol (right eye) and 2% rebamipide (left eye)

    3% diquafosol was instilled in the right eye and 2% rebamipide in the left eye.

  • Drug2% rebamipide (right eye) and 3% diquafosol (left eye)

    2% rebamipide was instilled in the right eye and 3% diquafosol in the left eye.

06

What researchers measure

Primary outcomes

  1. visual analog scale (VAS) score

    Unit: points

    Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

  2. tear breakup time (TBUT)

    Unit: Seconds

    Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

  3. ocular staining score (OSS)

    National Eye Institute Scale, 0-15

    Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

  4. tear meniscus height (TMH)

    Unit: mm

    Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

  5. lipid layer thickenss (LLT)

    Unit: nm

    Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

  6. corneal sensitivity (esthesiometer)

    Unit: mm

    Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

Secondary outcomes

  1. tear MUC1 concentration

    measured using enzyme-linked immunosorbent assay (ELISA)

    Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

  2. tear MUC5AC concentration

    measured using enzyme-linked immunosorbent assay (ELISA)

    Time frame: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops

07

Study locations

1 site
  • Korea University Anam Hospital
    Seoul, 02841, South Korea
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07297316
Lead sponsor
Korea University Anam Hospital
Collaborators
Kukje Pharma
Responsible party
Dong Hyun Kim (Principal Investigator, Korea University Anam Hospital) — Principal investigator
First posted
Dec 22, 2025
Start date
Oct 3, 2022
Primary completion
Aug 30, 2024
Completion
Aug 30, 2024
Last update
Dec 22, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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