Efficacy and Safety Study of HU00701/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

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

Brief Summary

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A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HU00701

HU00701(Cyclosporine 0.01% + 3% trehalose)

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

Group Type EXPERIMENTAL

HU00701

Intervention Type DRUG

Cyclosporine 0.01% + 3% trehalose

HU007

HU007(Cyclosporine 0.02% + 3% trehalose)

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

Group Type EXPERIMENTAL

HU007

Intervention Type DRUG

Cyclosporine 0.02% + 3% trehalose

Restasis

Restasis(Cyclosporine 0.05%)

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

Group Type ACTIVE_COMPARATOR

Restasis

Intervention Type DRUG

Cyclosporine 0.05%

Placebo(without main component)

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle

Interventions

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HU00701

Cyclosporine 0.01% + 3% trehalose

Intervention Type DRUG

HU007

Cyclosporine 0.02% + 3% trehalose

Intervention Type DRUG

Restasis

Cyclosporine 0.05%

Intervention Type DRUG

Placebo

Vehicle

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
* Volunteer who has negative result of pregnancy test or use effective contraception

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
* Wearing contact lenses within 3 days of screening visit
* Pregnancy or Breastfeeding

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes