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

Huons

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndrome

Treatments: Drug: Moisview; Drug: Restasis; Drug: HU007

Study type: Interventional

Funder types: Industry

Identifiers

NCT03461575

HU-007_P3

Details and patient eligibility

About

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

Enrollment: 209 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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209 participants in 3 patient groups

HU007

Experimental group

Description:

Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks

Treatment:

Drug: HU007

Restasis

Active Comparator group

Description:

Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks

Treatment:

Drug: Restasis

Moisview

Active Comparator group

Description:

trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks

Treatment:

Drug: Moisview