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OpenTrials
Completed

NCT Number: NCT03461575

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

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

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul ST.Mary's Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HU007

Drug

cyclosporine 0.02%, trehalose 3%

Restasis

Drug

cyclosporine 0.05%

Moisview

Drug

trehalose 3%

Primary outcomes

  1. change from Baseline in Corneal staining(Oxford grading) score

    Time frame: Week 12

Secondary outcomes

  1. change from Baseline in Corneal staining(Oxford grading) score

    Time frame: Week 4,8

  2. change from Baseline of Conjunctival staining(Oxford grading) score

    Time frame: Week 4,8,12

  3. change from Baseline of Strip meniscometry assessment

    Time frame: Week 4,8,12

  4. change from Baseline of Tear film break-up time

    Time frame: Week 4,8,12

  5. change from Baseline of Standard patient evaluation of eye dryness questionnaire

    Time frame: Week 4,8,12

  6. arrival time of 100% clearence in Corneal staining test

    Time frame: Week 0-12

  7. The number of total rescue drug usage

    Time frame: Week 0-12

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 12, 2018
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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