HU007 in Patients With Dry Eye Syndrome

• Sponsor: Huons Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05743764
• Collaborator: (none)
• Enrollment: 328
• Arms: 3
• Anticipated Duration (Months): 12

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: HU007; Drug: Restasis; Drug: Moisview Eye drop	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 328 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official 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
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. change from Baseline in Corneal staining(Oxford grading) score [Week12]

   change from Baseline in Corneal staining(Oxford grading) score - Oxford grading:0(Absent) to 5(Severe)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit.

Exclusion Criteria:

• The 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 of screening visit

• Pregnancy or Breastfeeding

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Huons Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Huons Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05743764
• Other Study ID Numbers: HUC2-007_P3-2
• First Posted: Feb 24, 2023
• Last Update Posted: Feb 24, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Ophthalmic Solutions

Study Results

No Results Posted as of Feb 24, 2023