Once-daily Fluorometholone vs Twice-daily Cyclosporine in Dry Eye Disease
NCT ID: NCT06876116
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2022-09-01
2024-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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once-daily fluorometholone 0.1% group
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.
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
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Taejoon Pharmaceutical Co., Ltd.
INDUSTRY
Korea University Anam Hospital
OTHER
Responsible Party
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Dong Hyun Kim
Principal Investigator
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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2022AN0569
Identifier Type: -
Identifier Source: org_study_id
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