Clinical trial NCT01804361: Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes
Official title: Efficacy and Safety Study of Haporine-S in Subjects With Moderate to Severe Dry Eye, A Multicenter, Investigator(Assessor)Blind, Parallel Design, Non-inferiority Phase III Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Syndromes
Lead sponsor: DH Bio Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: BTO Pharm. Co., Ltd.
First posted: 2013-03-05
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.

Detailed description: This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial.

Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.

Eligibility criteria: Inclusion Criteria:

* Male or female, age 20 or over
* Patients with moderate to severe dry eye(DEWS Level II or over)
* Be informed of the nature of the study and will give written informed consent

Exclusion Criteria:

* Being treated with steroidal eye drop or non-steroidal anti-inflammatory eye drop for dry eye
* Being treated with systemic steroid or immunosuppressive
* History of eyeball surgical operation within 6 months
* Wearing contact lenses during participation of the study
* Pregnancy or breastfeeding
* Use of cyclosporine eye drop within 2 weeks
* Intraocular pressure(IOP)\> 25 mmHg
* History of punctal occlusion within 1 month or during participation of the study
* Hypersensitivity to the investigational products or be suspicious to them
* Patients whom the investigator considers inappropriate to participate in the study

Primary outcomes:
measure: Corneal staining
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Ocular Surface Disease Index(OSID)
timeFrame: 0 day, 4 weeks and 12 weeks
measure: Tear Breakup Time(TBUT)
timeFrame: 0 day, 4 weeks and 12 weeks
measure: Schirmer score
timeFrame: 0 day, 4 weeks and 12 weeks
measure: Drug compliance
timeFrame: 0 day, 4 weeks and 12 weeks
measure: DEWS(Dry Eye WorkShop) level
timeFrame: 0 day, 4 weeks and 12 weeks
Other outcomes:
measure: Adverse Events
timeFrame: 1 year
measure: Serious Adverse Events
timeFrame: 1 year
Locations:
city: Busan
country: Korea, Republic of
facility: Busan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Hyo-Myung KIM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: Jong Suk SONG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yonsei University Gangnam Severance Hospital
name: Hyung Keun LEE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Busan National University Hospital
name: Jong-Soo LEE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Mee Kum KIM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Myoung-Joon KIM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: