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Completed

NCT Number: NCT02917512

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

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

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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 2

Primary location

Huons

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

Who can participate

Healthy volunteers accepted: Yes

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
  • 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

Treatment and study plan

HU00701

Drug

Cyclosporine 0.01% + 3% trehalose

HU007

Drug

Cyclosporine 0.02% + 3% trehalose

Restasis

Drug

Cyclosporine 0.05%

Placebo

Drug

Vehicle

Primary outcomes

  1. change from Baseline of Corneal staining score - Oxford grading

    Time frame: Week 12

Secondary outcomes

  1. change from Baseline of Corneal staining score - Oxford grading

    Time frame: Week 4, 8

  2. change from Baseline of Strip meniscometry assessment

    Time frame: Week 4, 8, 12

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

    Time frame: Week 4, 8, 12

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

    Time frame: Week 4, 8, 12

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 28, 2016
Registry last updated
Apr 12, 2018

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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