HU007 in Patients with Dry Eye Syndrome

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

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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