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

Phase 3

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: HU007; Drug: Moisview; Drug: Restasis

• Registration Number: NCT03461575
• Lead Sponsor: Huons Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-12
• Status Verified: 2018-04
• Primary Completion: 2018-07-12
• Study Completion: 2018-07-12
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
HU007	HU007	Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks
Moisview	Moisview	trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks
Restasis	Restasis	Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks

Primary Outcome Measures

Name	Time	Method
change from Baseline in Corneal staining(Oxford grading) score	Week 12

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul ST.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of