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Completed

NCT Number: NCT05743764

HU007 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 Disease 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

Gyeongsang National University Hospital

Jinju, 52727, 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 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 in at least one of both eyes
  • Patients who have had more than one symptom of dry eye disease for at least 3 month before screening visit
  • Best corrected visual acuity of 0.2 or higher in both eyes
  • Those who voluntarily decided to participate and agreed in writing to comply with the precautions

Exclusion criteria

  • Patients with clinically significant ocular disorders affected the test result
  • Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
  • SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c > 9%
  • Wearing contact lenses within 72 hr prior to screening visit or during clinical trial
  • Pregnancy or Breastfeeding
  • Patient with a history of glaucoma, or intraocular pressure of 25mmHg or higher at least one eyes
  • Patient with autoimmune disease (e.g. sjogren's syndrome)
  • Patients with a history of corneal transplant or neurotrophic keratitis

Treatment and study plan

HU007

Drug

cyclosporine 0.02%, trehalose 3%

Restasis

Drug

cyclosporine 0.05%

Moisview Eye drop

Drug

trehalose 3%

Primary outcomes

  1. Change from baseline in corneal staining score

    Time frame: 12weeks

    Change in corneal staining score assessed on Oxford grading at 12 weeks compared to baseline

    • Oxford grading: 0(Absent) to 5(Severe)

Secondary outcomes

  1. Change from baseline in corneal staining score

    Time frame: 4, 8weeks

    Change in corneal staining score assessed on Oxford grading at 4, 8 weeks compared to baseline

  2. Change from baseline in conjuctival staining score

    Time frame: 4, 8, 12weeks

    Change in conjuctival staining score assessed on Oxford grading at 4, 8, 12 weeks compared to baseline

  3. Change from baseline in strip meniscometry score

    Time frame: 4, 8, 12weeks

    Change in strip meniscometry score at 4, 8, 12 weeks compared to baseline

  4. Change from baseline in TBUT score

    Time frame: 4, 8, 12weeks

    Change in TBUT score at 4, 8, 12 weeks compared to baseline

  5. Change from baseline in SPEED dry eye questionnaire score

    Time frame: 4, 8, 12weeks

    Change in SPEED dry eye questionnaire score at 4, 8, 12 weeks compared to baseline

  6. Time to achieve 100% clearance in corneal staining

    Time frame: 12weeks

    Time to achieve 100% clearance in corneal staining up to 12 weeks

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
2023
Primary completion
2024
Study completion
2024
First posted
Feb 24, 2023
Registry last updated
Sep 26, 2024

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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