NCT01804361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

February 27, 2013

Last Update Submit

July 20, 2015

Conditions

Dry Eye Syndromes

Keywords

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • Corneal staining

    Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

    up to 12 weeks

Secondary Outcomes (5)

  • Ocular Surface Disease Index(OSID)

    0 day, 4 weeks and 12 weeks

  • Tear Breakup Time(TBUT)

    0 day, 4 weeks and 12 weeks

  • Schirmer score

    0 day, 4 weeks and 12 weeks

  • Drug compliance

    0 day, 4 weeks and 12 weeks

  • DEWS(Dry Eye WorkShop) level

    0 day, 4 weeks and 12 weeks

Other Outcomes (2)

  • Adverse Events

    1 year

  • Serious Adverse Events

    1 year

Study Arms (2)

Haporine-S

EXPERIMENTAL

Moderate to severe dry patients administered with with Haporine-S

Drug: Haporine-S

Restasis, Cyclosporine 0.05%

ACTIVE COMPARATOR

Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%)

Drug: Restasis (cyclosporine 0.05%)

Interventions

Haporine-SDRUG

1 or 2 drops twice a day at 12 hour interval for 12 weeks

Haporine-S
Restasis (cyclosporine 0.05%)DRUG

1 or 2 drops twice a day at 12 hour interval for 12 weeks

Restasis, Cyclosporine 0.05%

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Busan National University Hospital

Busan, Busan, 602-739, South Korea

Location

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Yonsei University Gangnam Severance Hospital

Seoul, Seoul, 135-720, South Korea

Location

Korea University Anam Hospital

Seoul, Seoul, 136-705, South Korea

Location

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

Location

Korea University Guro Hospital

Seoul, Seoul, 152-703, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Hyo-Myung KIM, MD, PhD

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

  • Jong Suk SONG, MD, PhD

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

  • Hyung Keun LEE, MD, PhD

    Yonsei University Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

  • Jong-Soo LEE, MD, PhD

    Busan National University Hospital

    PRINCIPAL INVESTIGATOR

  • Mee Kum KIM, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

  • Myoung-Joon KIM, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 5, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations

KR(6)