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
Not provided
Not provided
Not provided
Not provided
In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJO-083 | Experimental | TJO-083 : 1 drop 3 times a day |
|
| Diquas-s Ophthalmic solution 3% 0.4mL | Active Comparator | 1 drop 6 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJO-083 | Drug | Diquafosol ophthalmic sodium solution, 1 drop 3 times a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Corneal Staining at Week 4 | Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 4. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Corneal Staining at Week 8, 12 | Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 8, 12. | Baseline and Week 8 and 12 |
| Change From Baseline in Conjunctival Staining at Week 4, 8 and 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taejoon Pharmaceutical Co., Ltd. | Seoul | Seoul | South Korea |
Not provided
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
A Multicenter, Randomized, Double-blind, Active control for Evaluating the Efficacy and Safety of the test drug(TJO-083) Compared with the control drug in Dry Eye Sydrome
Not provided
Not provided
Not provided
| Diquafosol ophthalmic sodium solution 3% |
| Drug |
Diquafosol ophthalmic sodium solution, 1 drop 6 times a day |
|
Change From Baseline in Conjunctival Staining using Rose Bengal staining procedure at Week 4, 8 and 12
| Baseline and Week 4, 8 and 12 |
| Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12 | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. | Baseline and Week 4, 8 and 12 |