Efficacy and Safety of HE10 for Dry Eye Syndrome
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|ClinicalTrials.gov Identifier: NCT02492412|
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : July 8, 2015
Huons Co., Ltd.
Information provided by (Responsible Party):
Huons Co., Ltd.
The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndrome||Drug: HE 10 Drug: Restasis||Phase 3|
This study is to compare the efficacy and safety of HE10 and Restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority Phase III clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects With Dry Eye Syndrome|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||September 2014|
Drug: HE10 1~2 drops b.i.d at 12 hour interval for 12 weeks
Drug: HE 10
Active Comparator: Restasis
Drug: Restasis(Cyclosporine 0.05%) 1~2 drops b.i.d at 12 hour interval for 12 weeks
Other Name: 0.05% cyclosporine
Primary Outcome Measures :
- Corneal staining Test to assess eye dryness [ Time Frame: 12 weeks ]Change from baseline in eye dryness at 12 weeks
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