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

Seasonal Allergic Conjunctivitis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06212973
Study type	Interventional
Source	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Contact
Status	Completed
Phase	Phase 3
Start date	March 13, 2023
Completion date	November 2, 2023

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See also
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