HU007 in Patients With Dry Eye Syndrome

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huons Co., Ltd.
• Treatments: Ophthalmic Solutions

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

• 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