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Completed

NCT Number: NCT04384991

HU007 Eye Drops in Patients With Dry Eye Syndrome

This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, 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 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 National University Bundang Hospital

Seongnam, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and Female who over 19 years old
  • Those who meet below criteria at least one of two eyes
  • Those who have over than score 2 in corneal staining test-Oxford grading
  • Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
  • TBUT(Tear film break-up time) test result should be under 10sec.
  • Woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, Women or men who have agreed to maintain at least one contraceptive method during study period
  • Those who could understand this study and agree to informed consent voluntarily

Exclusion criteria

  • Those who have clinically significant eye disease not related to dry eye symdrome
  • Those who are in anti-inflammatory medication for dry eye syndrome
  • Medication of systemic steroid or immunosuppressant
  • Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
  • Those who have medical history with intraocular surgery 90 days before screening visit
  • Those who have any active ophthalmic diseases such as active allergy, anterior uveitis, stevens-johnson syndrom which could affect the surfece of eye
  • Those who have any autoimmune diseases
  • Those who need a surgery for surface elevation caused by meibomian gland dysfunction(MGD)
  • Those who have any medical history of corneal transplantation or neurotrophic keratitis
  • Those who have diagnosed with glaucoma or have an intraocular pressure over than 25mmHg at least in one of the eyes
  • Those who have medicated cyclosporine or steroid eye-drops 30 days before screening visit
  • Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
  • Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
  • Those who have a hypersensitivity reaction for cyclosporine, trehalose or protein-based medication related to investigational drug
  • Those who have diagnosed a psychical disorder which could affect this study
  • Women who is pregnant or breastfeeding or those who have a plan to be pregnant
  • Those who have medical history on abusing medications or alchol
  • Those who have received other investigational drugs/devices 30 days before screening visit
  • Those who are inappropriate for participating in this study according to investigator's judgement

Treatment and study plan

HU007

Drug

Cyclosporine 0.02% with Trehalose 3%

Restasis eye drop

Drug

Cyclosporine 0.05%

Primary outcomes

  1. Change from baseline in corneal staining score-Oxford grading

    Time frame: Week 12

    Change from baseline in corneal staining score-Oxford grading at Week 12

Secondary outcomes

  1. Change from baseline in corneal staining score-Oxford grading

    Time frame: Week 4, 8

    Change from baseline in corneal staining score-Oxford grading at Week 4, 8

  2. Change from baseline in conjunctival staining score-Oxford grading

    Time frame: Week 4, 8, 12

    Change from baseline in conjunctival staining score-Oxford grading at Week 4, 8, 12

  3. Change from baseline in strip meniscometry

    Time frame: Week 4, 8, 12

    Change from baseline in strip meniscometry at Week 4, 8, 12

  4. Change from baseline in Tear film break-up time

    Time frame: at Week 4, 8, 12

    Change from baseline in Tear film break-up time at Week 4, 8, 12

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

    Time frame: at Week 4, 8, 12

    Change from Baseline of Standard patient evaluation of eye dryness questionnaire at Week 4, 8, 12

  6. Time to achieve 100% clearance on the corneal staining score

    Time frame: upto week 12

    Time to achieve 100% clearance on the corneal staining score

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double Blind, Restasis-controlled Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 12, 2020
Registry last updated
May 12, 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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