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This is a prospective randomized study compared with active control and placebo arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJO-083 [Part 2] | Experimental | 1 drop 3 times a day |
|
| Placebo of TJO-083 [Part 2] | Placebo Comparator | 1 drop 6 times a day |
|
| Diquas-s Ophthalmic solution 3% 0.4mL [Part 2] | 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 |
|---|---|---|
| Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1] | Changes from Baseline in tolerability questionnaire in 4 point scale at Day 2, 8. The including lists are below. Stinging/Burning, Itching, Blurred vision, Sandiness/Grittiness, Dryness, Light sensitivity, Pain or soreness, Hyperemia. | Baseline and Day 2, 8 |
| Change From Baseline in Corneal Staining in 9 point Score at Week 4 [Part 2] | Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure in 9 point scare at Week 4. (As the score high, the condition of eye is worse) | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2] | 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 2, 4, 8 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sukyoung Kwon | Contact | 82-2-799-0184 | skkwon@taejoon.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hyung Keun Lee, MD | Gangnam Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyung Keun, Lee | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Placebo (vehicle) |
| Other |
1 drop 6 times a day |
|
| Diquafosol ophthalmic sodium solution 3% | Drug | Diquafosol ophthalmic sodium solution, 1 drop 6 times a day |
|