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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461575
• Other study ID #: HU-007_P3
• Status: Completed
• Phase: Phase 3
• Start date: January 22, 2018
• Est. completion date: July 12, 2018

Study information

• Verified date: April 2018
• Source: Huons Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• HU007
cyclosporine 0.02%, trehalose 3%
• Restasis
cyclosporine 0.05%
• Moisview
trehalose 3%

Locations

Country	Name	City	State
Korea, Republic of	Seoul ST.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from Baseline in Corneal staining(Oxford grading) score		Week 12
Secondary	change from Baseline in Corneal staining(Oxford grading) score		Week 4,8
Secondary	change from Baseline of Conjunctival staining(Oxford grading) score		Week 4,8,12
Secondary	change from Baseline of Strip meniscometry assessment		Week 4,8,12
Secondary	change from Baseline of Tear film break-up time		Week 4,8,12
Secondary	change from Baseline of Standard patient evaluation of eye dryness questionnaire		Week 4,8,12
Secondary	arrival time of 100% clearence in Corneal staining test		Week 0-12
Secondary	The number of total rescue drug usage		Week 0-12