NCT02492412

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2013

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

May 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

June 25, 2015

Last Update Submit

July 5, 2015

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • Corneal staining Test to assess eye dryness

    Change from baseline in eye dryness at 12 weeks

    12 weeks

Study Arms (2)

HE10

EXPERIMENTAL

Drug: HE10 1\~2 drops b.i.d at 12 hour interval for 12 weeks

Drug: HE 10

Restasis

ACTIVE COMPARATOR

Drug: Restasis(Cyclosporine 0.05%) 1\~2 drops b.i.d at 12 hour interval for 12 weeks

Drug: Restasis

Interventions

HE 10DRUG
HE10
RestasisDRUG
Also known as: 0.05% cyclosporine
Restasis

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Corneal staining score of ≥2(Oxford grade)
  • Schirmer test score (without anesthesia) \< 10 mm/5 min in either eye
  • Tear break-up time is 10 seconds or less
  • Screening both eyes, the corrected visual acuity is 0.2 or more

You may not qualify if:

  • Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
  • The patients with systemic or ocular disorders affected the test result
  • Being treated with systemic steroid
  • History of eyeball surgical operation within 3 months of screening visit
  • Wearing contact lenses within 2 weeks of screening visit
  • Be a use or used punctual plug within 1 month of screening vist
  • Use of cyclosporine eye drop within 3 weeks
  • Pregnancy or Breastfeeding
  • Intraocular pressure \> 25 mmHg
  • Abnormal eyelid function : Disorders of the eyelids or eyelashes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

CyclosporinsCyclosporine

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Design

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

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 8, 2015

Study Start

May 1, 2013

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

July 8, 2015

Record last verified: 2015-07