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
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Gyeongsang National University Hospital
Jinju
Time Frame
Start Date: 2023-03-23
Completion Date: 2024-02-14
Participants
Target number of participants: 328
Treatments
Experimental: HU007
Cyclosporine 0.02%, trehalose 3%~1 drop b.i.d at 12hr interval for 12 weeks
Active_comparator: Restasis
Cyclosporine 0.05%~1 drop b.i.d at 12hr interval for 12 weeks
Active_comparator: Moisview
trehalose 3%~1 drop b.i.d at 12hr interval for 12 weeks
Related Therapeutic Areas
Sponsors
Leads: Huons Co., Ltd.