Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome

Huons

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: Placebo; Drug: HU007; Drug: HU00701; Drug: Restasis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02917512

HU-007_P2

Details and patient eligibility

About

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

Enrollment: 114 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 4 patient groups, including a placebo group

HU00701

Experimental group

Description:

HU00701(Cyclosporine 0.01% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks

Treatment:

Drug: HU00701

HU007

Experimental group

Description:

HU007(Cyclosporine 0.02% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks

Treatment:

Drug: HU007

Restasis

Active Comparator group

Description:

Restasis(Cyclosporine 0.05%) 1 drop b.i.d at 12 hour interval for 12 weeks

Treatment:

Drug: Restasis

Placebo(without main component)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo