Status:
COMPLETED
Once-daily Fluorometholone vs Twice-daily Cyclosporine in Dry Eye Disease
Lead Sponsor:
Korea University Anam Hospital
Collaborating Sponsors:
Taejoon Pharmaceutical Co., Ltd.
Conditions:
Dry Eye Disease (DED)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06876116
Start Date
September 1 2022
End Date
May 24 2024
Last Update
March 14 2025
Active Locations (1)
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1
Korea University Anam Hospital
Seoul, South Korea, 02841