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Completed

NCT Number: NCT07297316

Immediate Therapeutic Effects of Diquafosol and 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.

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Anam Hospital

Seoul, 02841, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

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.

Primary outcomes

  1. visual analog scale (VAS) score

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

    Unit: points

  2. tear breakup time (TBUT)

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

    Unit: Seconds

  3. ocular staining score (OSS)

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

    National Eye Institute Scale, 0-15

  4. tear meniscus height (TMH)

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

    Unit: mm

  5. lipid layer thickenss (LLT)

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

    Unit: nm

  6. corneal sensitivity (esthesiometer)

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

    Unit: mm

Secondary outcomes

  1. tear MUC1 concentration

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

    measured using enzyme-linked immunosorbent assay (ELISA)

  2. tear MUC5AC concentration

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

    measured using enzyme-linked immunosorbent assay (ELISA)

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • Kukje Pharma

Registry information

Official study title

Comparison of Immediate Therapeutic Effects of 3% Diquafosol and 2% Rebamipide in Dry Eye Disease

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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