NCT06212973

A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients

A Phase 3, Multicenter, Randomized, Double-masked, Active Controlled Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops 0.05% in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The goal of this multicenter, randomized, double-blind, active control, non-inferiority clinical trial is to evaluate the efficacy of epinastine hydrochloride eye drops for the treatment of seasonal allergic conjunctivitis using azelastine hydrochloride eye drops as a positive control in Chinese patients. The main question it aims to answer are: • Is the efficacy for of epinastine hydrochloride eye drops for the treatment of seasonal allergic conjunctivitis non-inferior to azelastine hydrochloride eye drops?Participants will be randomly assigned to the test group or control group in a 1:1 ratio. The test group was treated with epinastine hydrochloride eye drops + azelastine hydrochloride simulating eye drops, and the control group was treated with azelastine hydrochloride eye drops + epinastine hydrochloride simulating eye drops, which were used twice a day for 14 consecutive days.

Conditions

• Seasonal Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln	Epinastine Hydrochloride Eye Drops + Simulating Azelastine Hydrochloride Eye Drops are used: both eyes are administered twice daily, once in the morning and once in the evening, with an interval of 8-12 hours between administrations; each time, 1 drop of each of the two eye drops is placed in each eye into the conjunctiva, and the two eye drops are applied at intervals of more than 5 minutes.
DRUG	Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln	Azelastine Hydrochloride Eye Drops + Simulating Epinastine Hydrochloride Eye Drops are used: both eyes are administered twice daily, once in the morning and once in the evening, with an interval of 8-12 hours between administrations; each time, 1 drop of each of the two eye drops is placed in each eye into the conjunctiva, and the two eye drops are applied at intervals of more than 5 minutes.

Timeline

• Start date: 2023-03-13
• Primary completion: 2023-11-02
• Completion: 2023-11-02
• First posted: 2024-01-19
• Last updated: 2024-01-19

Locations

1 site across 1 country: China