Efficacy and Safety of HE10 for Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492412
• Other study ID #: Huons
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2015
• Last updated: July 5, 2015
• Start date: May 2013
• Est. completion date: September 2014

Study information

• Verified date: July 2015
• Source: Huons Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• HE 10

• Restasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co.,Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal staining Test to assess eye dryness	Change from baseline in eye dryness at 12 weeks	12 weeks	No