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

Sponsor
Huons Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03461575
Collaborator
(none)
209
1
3
5.6
37.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
209 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 22, 2018
Actual Primary Completion Date :
Jul 12, 2018
Actual Study Completion Date :
Jul 12, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: HU007

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

Drug: HU007
cyclosporine 0.02%, trehalose 3%

Active Comparator: Restasis

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

Drug: Restasis
cyclosporine 0.05%

Active Comparator: Moisview

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

Drug: Moisview
trehalose 3%

Outcome Measures

Primary Outcome Measures

  1. change from Baseline in Corneal staining(Oxford grading) score [Week 12]

Secondary Outcome Measures

  1. change from Baseline in Corneal staining(Oxford grading) score [Week 4,8]

  2. change from Baseline of Conjunctival staining(Oxford grading) score [Week 4,8,12]

  3. change from Baseline of Strip meniscometry assessment [Week 4,8,12]

  4. change from Baseline of Tear film break-up time [Week 4,8,12]

  5. change from Baseline of Standard patient evaluation of eye dryness questionnaire [Week 4,8,12]

  6. arrival time of 100% clearence in Corneal staining test [Week 0-12]

  7. The number of total rescue drug usage [Week 0-12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul ST.Mary's Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Huons Co., Ltd.

Investigators

  • Study Director: Namsick Kim, Huons Co., Ltd.
  • Principal Investigator: Choun-Ki Joo, Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huons Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03461575
Other Study ID Numbers:
  • HU-007_P3
First Posted:
Mar 12, 2018
Last Update Posted:
May 8, 2020
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 8, 2020