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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02492412

Enrollment

101

Registered

2015-07-08

Start date

2013-05-31

Completion date

2014-09-30

Last updated

2015-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

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.

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.

Interventions

DRUGHE 10

DRUGRestasis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026