HU007 in Patients with Dry Eye Syndrome

NCT05743764 | Completed Phase 3

• 1 other identifier: HUC2-007_P3-2
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in corneal staining score

  Change in corneal staining score assessed on Oxford grading at 12 weeks compared to baseline \- Oxford grading: 0(Absent) to 5(Severe)

  12weeks

Secondary Outcomes (6)

• Change from baseline in corneal staining score

  4, 8weeks

• Change from baseline in conjuctival staining score

  4, 8, 12weeks

• Change from baseline in strip meniscometry score

  4, 8, 12weeks

• Change from baseline in TBUT score

  4, 8, 12weeks

• Change from baseline in SPEED dry eye questionnaire score

  4, 8, 12weeks

Study Arms (3)

HU007

EXPERIMENTAL

Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks

Drug: HU007

Restasis

ACTIVE COMPARATOR

Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks

Drug: Restasis

Moisview

ACTIVE COMPARATOR

trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks

Drug: Moisview Eye drop

Interventions

HU007 DRUG

cyclosporine 0.02%, trehalose 3%

HU007

Restasis DRUG

cyclosporine 0.05%

Restasis

Moisview Eye drop DRUG

trehalose 3%

Moisview

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Gyeongsang National University Hospital

Jinju, 52727, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jun young Hyun

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: March 23, 2023
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)