Dry Eye Disease (DED)
Conditions
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.
Interventions
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.
Sponsors
Taejoon Pharmaceutical Co., Ltd.
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tear osmolarity | From enrollment to the end of treatment at 12 weeks | Unit: mOsm/L |
| tear matrix metalloproteinase-9 (MMP-9) grade | From enrollment to the end of treatment at 12 weeks | Grade 0-4 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tear 8-oxo-dG levels | From enrollment to the end of treatment at 12 weeks | Unit: pg/mL |
| Tear IL-6 levels | From enrollment to the end of treatment at 12 weeks | Unit: pg/mL |
Countries
South Korea
Outcome results
None listed