Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2018-07-12

Brief Summary

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A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome

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Detailed Description

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Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HU007

Cyclosporine 0.02%, trehalose 3%

1 drop b.i.d at 12hr interval for 12 weeks

Group Type EXPERIMENTAL

HU007

Intervention Type DRUG

cyclosporine 0.02%, trehalose 3%

Restasis

Cyclosporine 0.05%

1 drop b.i.d at 12hr interval for 12 weeks

Group Type ACTIVE_COMPARATOR

Restasis

Intervention Type DRUG

cyclosporine 0.05%

Moisview

trehalose 3%

1 drop b.i.d at 12hr interval for 12 weeks

Group Type ACTIVE_COMPARATOR

Moisview

Intervention Type DRUG

trehalose 3%

Interventions

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HU007

cyclosporine 0.02%, trehalose 3%

Intervention Type DRUG

Restasis

cyclosporine 0.05%

Intervention Type DRUG

Moisview

trehalose 3%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age over 19
* Corneal staining score(Oxford grading) ≥ 2 or Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min)
* Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause or who has negative result of pregnancy test or use effective contraception

Exclusion Criteria

* The patients with systemic or ocular disorders affected the test result
* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
* Being treated with systemic steroid
* Wearing contact lenses within 72 hr of screening visit
* Pregnancy or Breastfeeding

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No