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

March 9, 2025 updated by: Dong Hyun Kim, Korea University Anam Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: once-daily fluorometholone 0.1% group
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.
Drug: Fluorometholone 0.1% ophthalmic solution
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.
Active Comparator: twice-daily cyclosporine 0.05% group
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.
Drug: Cyclosporine 0.05% eye drops
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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index (OSDI) score
Time Frame: From enrollment to the end of treatment at 12 weeks
Score 0-100
From enrollment to the end of treatment at 12 weeks
tear breakup time (TBUT)
Time Frame: From enrollment to the end of treatment at 12 weeks
Unit: Seconds
From enrollment to the end of treatment at 12 weeks
corneal staining score (CSS)
Time Frame: From enrollment to the end of treatment at 12 weeks
National Eye Institute Scale, 0-15
From enrollment to the end of treatment at 12 weeks
Schirmer's test
Time Frame: From enrollment to the end of treatment at 12 weeks
Unit: mm/5 min
From enrollment to the end of treatment at 12 weeks
Meibomian gland dysfunction grade (0-4)
Time Frame: From enrollment to the end of treatment at 12 weeks
Scale 0-4
From enrollment to the end of treatment at 12 weeks
tear matrix metalloproteinase-9 (MMP-9) grade
Time Frame: From enrollment to the end of treatment at 12 weeks
Grade 0-4
From enrollment to the end of treatment at 12 weeks
tear osmolarity
Time Frame: From enrollment to the end of treatment at 12 weeks
Unit: mOsm/L
From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear IL-6 levels
Time Frame: From enrollment to the end of treatment at 12 weeks
Unit: pg/mL
From enrollment to the end of treatment at 12 weeks
tear 8-oxo-dG levels
Time Frame: From enrollment to the end of treatment at 12 weeks
Unit: pg/mL
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Collaborators

Taejoon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

May 24, 2024

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022AN0569

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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