Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Taejoon Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| once-daily fluorometholone 0.1% group | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorometholone 0.1% ophthalmic solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI) score | Score 0-100 | From enrollment to the end of treatment at 12 weeks |
| tear breakup time (TBUT) | Unit: Seconds | From enrollment to the end of treatment at 12 weeks |
| corneal staining score (CSS) | National Eye Institute Scale, 0-15 | From enrollment to the end of treatment at 12 weeks |
| Schirmer's test | Unit: mm/5 min | From enrollment to the end of treatment at 12 weeks |
| Meibomian gland dysfunction grade (0-4) | Scale 0-4 | From enrollment to the end of treatment at 12 weeks |
| tear matrix metalloproteinase-9 (MMP-9) grade | Grade 0-4 | From enrollment to the end of treatment at 12 weeks |
| tear osmolarity | Unit: mOsm/L | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tear IL-6 levels | Unit: pg/mL | From enrollment to the end of treatment at 12 weeks |
| tear 8-oxo-dG levels | Unit: pg/mL | From enrollment to the end of treatment at 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005469 | Fluorometholone |
| D009883 | Ophthalmic Solutions |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cyclosporine 0.05% eye drops | Drug | 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. |
|
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |