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Completed

NCT Number: NCT06876116

Once-daily Fluorometholone vs Twice-daily Cyclosporine in Dry Eye Disease

This study compares the therapeutic effects of once-daily fluorometholone 0.1% versus twice-daily cyclosporine 0.05% after short-term fluorometholone induction treatment 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

18 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

  • participants aged 18 years or older
  • complaint of dry eye symptoms for 6 months or longer at screening
  • ocular surface disease index (OSDI) score of 33 or higher
  • tear film breakup time of 7 seconds or less

Exclusion criteria

  • abnormal lid anatomy or active blepharitis
  • severe systemic autoimmune diseases
  • received permanent lacrimal plug within 3 months
  • DED secondary to alkali burns, cicatricial pemphigoid, or Stevens-Johnson syndrome
  • ocular/periocular malignancy
  • active ocular allergies or allergy to the study drug or its components
  • active infection
  • intraocular surgery or ocular laser surgery within 6 months
  • uncontrolled systemic disease or history of herpetic keratitis
  • contact lens user
  • intraocular pressure >25mmHg
  • pregnancy or current breast-feeding.

Treatment and study plan

Fluorometholone 0.1% ophthalmic solution

Drug

After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with fluorometholone 0.1% once a day for 8 weeks.

Cyclosporine 0.05% eye drops

Drug

After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with cyclosporine 0.05% twice a day for 8 weeks.

Other names: fluorometholone 0.1%

Primary outcomes

  1. Ocular Surface Disease Index (OSDI) score

    Time frame: From enrollment to the end of treatment at 12 weeks

    Score 0-100

  2. tear breakup time (TBUT)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Unit: Seconds

  3. corneal staining score (CSS)

    Time frame: From enrollment to the end of treatment at 12 weeks

    National Eye Institute Scale, 0-15

  4. Schirmer's test

    Time frame: From enrollment to the end of treatment at 12 weeks

    Unit: mm/5 min

  5. Meibomian gland dysfunction grade (0-4)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Scale 0-4

  6. tear matrix metalloproteinase-9 (MMP-9) grade

    Time frame: From enrollment to the end of treatment at 12 weeks

    Grade 0-4

  7. tear osmolarity

    Time frame: From enrollment to the end of treatment at 12 weeks

    Unit: mOsm/L

Secondary outcomes

  1. Tear IL-6 levels

    Time frame: From enrollment to the end of treatment at 12 weeks

    Unit: pg/mL

  2. tear 8-oxo-dG levels

    Time frame: From enrollment to the end of treatment at 12 weeks

    Unit: pg/mL

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • Taejoon Pharmaceutical Co., Ltd.

Registry information

Official study title

Comparison of Therapeutic Effects of Once-daily Fluorometholone 0.1% Versus Twice-daily Cyclosporine 0.05% in Patients With Dry Eye Disease: A Randomized, Assessor-blinded Clinical Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 14, 2025
Registry last updated
Mar 14, 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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