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The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJO-087 | Experimental |
| |
| Cyclosporine 0.05% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJO-087 | Drug | Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Non-anesthetic Schirmer Test at Week 32 | 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 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24 | 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, Week 8, 16 and 24 |
| Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32 |
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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 |
|---|---|---|
| Hyo Myung Kim, MD, PhD | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyo Myung, Kim | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36450107 | Derived | Eom Y, Yoon KC, Kim HK, Song JS, Hyon JY, Kim HM. A Multicenter, Randomized, Double-Blind Evaluation of the Efficacy of TJO-087 Versus 0.05% Cyclosporine A in Moderate to Severe Dry Eye. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):27-35. doi: 10.1089/jop.2022.0119. Epub 2022 Nov 24. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Cyclosporine ophthalmic solution 0.05% |
| Drug |
Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day |
|
Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure. |
| Baseline, Week 8, 16, 24 and 32 |