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

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Placebo; Drug: HU007; Drug: HU00701; Drug: Restasis

• Registration Number: NCT02917512
• Lead Sponsor: Huons Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-28
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo(without main component)	Placebo	Placebo 1 drop b.i.d at 12 hour interval for 12 weeks
HU007	HU007	HU007(Cyclosporine 0.02% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks
HU00701	HU00701	HU00701(Cyclosporine 0.01% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks
Restasis	Restasis	Restasis(Cyclosporine 0.05%) 1 drop b.i.d at 12 hour interval for 12 weeks

Primary Outcome Measures

Name	Time	Method
change from Baseline of Corneal staining score - Oxford grading	Week 12

Secondary Outcome Measures

Name	Time	Method
change from Baseline of Corneal staining score - Oxford grading	Week 4, 8
change from Baseline of Strip meniscometry assessment	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

Trial Locations

Locations (1)

Huons; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of