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

Korea University Anam Hospital32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dry Eye Disease (DED)

Interventions

Fluorometholone 0.1% ophthalmic solutionDRUG

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 dropsDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Korea University Anam Hospital

Seoul, South Korea