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

NCT02917512 | Completed Phase 2

• 1 other identifier: HU-007_P2
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• change from Baseline of Corneal staining score - Oxford grading

  Week 12

Secondary Outcomes (4)

• 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

Study Arms (4)

HU00701

EXPERIMENTAL

HU00701(Cyclosporine 0.01% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks

Drug: HU00701

HU007

EXPERIMENTAL

HU007(Cyclosporine 0.02% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks

Drug: HU007

Restasis

ACTIVE COMPARATOR

Restasis(Cyclosporine 0.05%) 1 drop b.i.d at 12 hour interval for 12 weeks

Drug: Restasis

Placebo(without main component)

PLACEBO COMPARATOR

Placebo 1 drop b.i.d at 12 hour interval for 12 weeks

Drug: Placebo

Interventions

HU00701 DRUG

Cyclosporine 0.01% + 3% trehalose

HU00701

HU007 DRUG

Cyclosporine 0.02% + 3% trehalose

HU007

Restasis DRUG

Cyclosporine 0.05%

Restasis

Placebo DRUG

Vehicle

Placebo(without main component)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Huons

Seongnam-si, Gyeonggi-do, 13486, South Korea

Location

Related Publications (1)

• Shin J, Rho CR, Hyon JY, Chung TY, Yoon KC, Joo CK. A Randomized, Placebo-Controlled Phase II Clinical Trial of 0.01% or 0.02% Cyclosporin A with 3% Trehalose in Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2021 Jan-Feb;37(1):4-11. doi: 10.1089/jop.2020.0104.

  PMID: 33449860 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Seung-il Baek

  Huons Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 28, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)