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HU007 in Patients with Dry Eye Syndrome

H

Huons

Status and phase

Completed
Phase 3

Conditions

Dry Eye Disease

Treatments

Drug: Moisview Eye drop
Drug: Restasis
Drug: HU007

Study type

Interventional

Funder types

Industry

Identifiers

NCT05743764
HUC2-007_P3-2

Details and patient eligibility

About

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

Enrollment

328 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

328 participants in 3 patient groups

HU007
Experimental group
Description:
Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks
Treatment:
Drug: HU007
Restasis
Active Comparator group
Description:
Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks
Treatment:
Drug: Restasis
Moisview
Active Comparator group
Description:
trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks
Treatment:
Drug: Moisview Eye drop

Trial contacts and locations

1

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Central trial contact

Hyoju Pyo; Dawon Park

Data sourced from clinicaltrials.gov

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