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The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease.
- Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT), Non-anesthetic Schirmer test
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-sporin eye drop | Experimental | Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes |
|
| Restasis eye drop | Active Comparator | Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine ophthalmic solution | Drug | 1 drop twice/day for 12 weeks to both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal staining test | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal staining test | 4, 8 weeks | |
| Ocular surface disease index (OSDI) | 4, 8, 12 weeks | |
| Tear break up time (TBUT) |
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Inclusion Criteria:
[Patients with moderate-to-severe ocular dry eye]
Exclusion Criteria:
Screening visits in the previous 3 months (12 weeks) who participated in the clinical trials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions.
The patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
The use in clinical trials of drug hypersensitivity reactions in patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The catholic university of Korea seoul st. Mary's hospital | Seoul | Seocho-Ku | 137-701 | South Korea |
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| 4, 8, 12 weeks |
| Non-anesthetic Schirmer test | 4, 8, 12 weeks |
| Conjunctival staining | 4, 8, 12 weeks |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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