Efficacy and Safety of HE10 for Dry Eye Syndrome

Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects With Dry Eye Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: Restasis; Drug: HE 10

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HE10; 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	Drug: Restasis; Other Names: 0.05% cyclosporine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal staining Test to assess eye dryness	Change from baseline in eye dryness at 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: July 5, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 5, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: Huons