A Phase 4 interventional study of Fluorometholone 0.1% ophthalmic solution and Cyclosporine 0.05% eye drops in Dry Eye Disease (DED), sponsored by Korea University Anam Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Korea University Anam Hospital · Phase 4, Interventional, and Treatment
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Korea University Anam Hospital is the lead sponsor of 110 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 fluorometholone 0.1% once a day for 8 weeks.
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%
Ocular Surface Disease Index (OSDI) score
Score 0-100
Time frame: From enrollment to the end of treatment at 12 weeks
tear breakup time (TBUT)
Unit: Seconds
Time frame: From enrollment to the end of treatment at 12 weeks
corneal staining score (CSS)
National Eye Institute Scale, 0-15
Time frame: From enrollment to the end of treatment at 12 weeks
Schirmer's test
Unit: mm/5 min
Time frame: From enrollment to the end of treatment at 12 weeks
Meibomian gland dysfunction grade (0-4)
Scale 0-4
Time frame: From enrollment to the end of treatment at 12 weeks
tear matrix metalloproteinase-9 (MMP-9) grade
Grade 0-4
Time frame: From enrollment to the end of treatment at 12 weeks
tear osmolarity
Unit: mOsm/L
Time frame: From enrollment to the end of treatment at 12 weeks
Tear IL-6 levels
Unit: pg/mL
Time frame: From enrollment to the end of treatment at 12 weeks
tear 8-oxo-dG levels
Unit: pg/mL
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Korea University Anam Hospital