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A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HU00701 | Experimental | HU00701(Cyclosporine 0.01% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks |
|
| HU007 | Experimental | HU007(Cyclosporine 0.02% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks |
|
| Restasis | Active Comparator | Restasis(Cyclosporine 0.05%) 1 drop b.i.d at 12 hour interval for 12 weeks |
|
| Placebo(without main component) | Placebo Comparator | Placebo 1 drop b.i.d at 12 hour interval for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HU00701 | Drug | Cyclosporine 0.01% + 3% trehalose |
| |
| HU007 |
| Measure | Description | Time Frame |
|---|---|---|
| change from Baseline of Corneal staining score - Oxford grading | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| change from Baseline of Corneal staining score - Oxford grading | Week 4, 8 | |
| change from Baseline of Strip meniscometry assessment | Week 4, 8, 12 | |
| change from Baseline of Tear film break-up time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-il Baek | Huons Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huons | Seongnam-si | Gyeonggi-do | 13486 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33449860 | Derived | Shin J, Rho CR, Hyon JY, Chung TY, Yoon KC, Joo CK. A Randomized, Placebo-Controlled Phase II Clinical Trial of 0.01% or 0.02% Cyclosporin A with 3% Trehalose in Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2021 Jan-Feb;37(1):4-11. doi: 10.1089/jop.2020.0104. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Drug |
Cyclosporine 0.02% + 3% trehalose |
|
| Restasis | Drug | Cyclosporine 0.05% |
|
| Placebo | Drug | Vehicle |
|
| Week 4, 8, 12 |
| change from Baseline of Standard patient evaluation of eye dryness questionnaire | Week 4, 8, 12 |
| D000602 |
| Amino Acids, Peptides, and Proteins |