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

NCT06876116 | Completed Phase 4

• 1 other identifier: 2022AN0569
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (7)

• Ocular Surface Disease Index (OSDI) score

  Score 0-100

  From enrollment to the end of treatment at 12 weeks

• tear breakup time (TBUT)

  Unit: Seconds

  From enrollment to the end of treatment at 12 weeks

• corneal staining score (CSS)

  National Eye Institute Scale, 0-15

  From enrollment to the end of treatment at 12 weeks

• Schirmer's test

  Unit: mm/5 min

  From enrollment to the end of treatment at 12 weeks

• Meibomian gland dysfunction grade (0-4)

  Scale 0-4

  From enrollment to the end of treatment at 12 weeks

• tear matrix metalloproteinase-9 (MMP-9) grade

  Grade 0-4

  From enrollment to the end of treatment at 12 weeks

• tear osmolarity

  Unit: mOsm/L

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

• Tear IL-6 levels

  From enrollment to the end of treatment at 12 weeks

• tear 8-oxo-dG levels

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

once-daily fluorometholone 0.1% group

ACTIVE COMPARATOR

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

twice-daily cyclosporine 0.05% group

ACTIVE COMPARATOR

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

Interventions

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.

once-daily fluorometholone 0.1% group

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.

Also known as: fluorometholone 0.1%

twice-daily cyclosporine 0.05% group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Taejoon Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Fluorometholone; Ophthalmic Solutions; Cyclosporine

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 14, 2025
• Study Start: September 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: May 24, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)