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NCT02917512 Clinical Trial

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

Dry Eye Syndrome Clinical Trial

Official title:
A Multicenter, Placebo Controlled, Restasis® Referenced, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02917512
Other study ID # HU-007_P2
Secondary ID
Status Completed
Phase Phase 2
First received September 26, 2016
Last updated April 10, 2018
Start date March 2016
Est. completion date December 2016

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

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
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

- 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

Related Conditions & MeSH terms

Intervention

Drug:
• HU00701
Cyclosporine 0.01% + 3% trehalose
• HU007
Cyclosporine 0.02% + 3% trehalose
• Restasis
Cyclosporine 0.05%
• Placebo
Vehicle

Locations
Country Name City State
Korea, Republic of Huons Seongnam-si Gyeonggi-do

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 of Corneal staining score - Oxford grading Week 12
Secondary change from Baseline of Corneal staining score - Oxford grading Week 4, 8
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
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