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In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug.
Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Hyaluronate 0.15% mono-therapy | Experimental | HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks |
|
| Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy) | Active Comparator | CsA 0.05% + CMC 0.5% group was treated with CsA 0.05% two times daily and CMC 0.5% two ~ six times daily for 12 weeks. |
|
| HA 0.15% + CsA 0.05% (combination therapy) | Other | HA 0.15% + CsA 0.05% group was treated with HA 0.15% six times daily and CsA 0.05% twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJO-018 (HA 0.15%) | Drug | TJO-018 / one drop / 6 times daily in both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Corneal Staining Score at Week 12 | After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change.
| Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Corneal Staining Score at Week 4 and Week 8 | After 4, 8 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change.
| Baseline, Week 4 and Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taejoon Pharmaceutical Co., Ltd. | Seoul | South Korea |
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A Multicenter, Randomized, Single-blind Study for Evaluating the Efficacy of HA 0.15% Compared with Cyclosporine 0.05% in Moderate to Severe Dry Eye Syndrome
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| Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add) | Drug | Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two~six times daily in both eyes |
|
| TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05% | Drug | TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes |
|
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D059039 | Standard of Care |
| C035361 | MCC protocol |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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