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

Phase 4

Completed

• Conditions: Dry Eye Disease (DED)
• Interventions: Drug: Fluorometholone 0.1% ophthalmic solution; Drug: Cyclosporine 0.05% eye drops

• Registration Number: NCT06876116
• Lead Sponsor: Korea University Anam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-05-24
• Study First Submitted: 2025-02-25
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-09
• Last Update Submitted: 2025-03-09
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
once-daily fluorometholone 0.1% group	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.
twice-daily cyclosporine 0.05% group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of