NCT06388070

To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome

A Multicenter, Randomized, Double-blinded, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared With Hyalein Mini Eye Drops in Patients With Dry Eye Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: Huons Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome. After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Eye Drops administered bilaterally five to six times a day for 12 weeks.

Detailed description

This is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome. During a 2-week study run-in period prior to randomization, all subjects will receive rescue drug bilaterally up to 4 times a day. Randomization will then occur as 1:1 where patients will be assigned to receive HUC3-053 or Hyalein Mini Eye Drops given bilaterally five to six times a day. The treatment period is 12 weeks.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	HA 0.3%	Instillation in each eye five to six times a day for 12 weeks
DRUG	Hyalein Mini Eye Drops	Instillation in each eye five to six times a day for 12 weeks.

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-03-14
• Completion: 2025-03-21
• First posted: 2024-04-29
• Last updated: 2026-03-05

Locations

1 site across 1 country: South Korea