Dichang Pharma Initiates Phase III Clinical Trial of Azithromycin Eye Drops for Purulent Bacterial Conjunctivitis

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a multi-center, randomized, double-blind, placebo-controlled parallel Phase III clinical study evaluating the efficacy and safety of Azithromycin Eye Drops in Chinese patients with purulent bacterial conjunctivitis, conducted by Nanjing Dichang Pharmaceutical Technology Co., Ltd. / Unither Pharmaceuticals (Nanjing), has been initiated. The clinical trial registration number is CTR20253839, with the initial information disclosure date on October 9, 2025.

The drug formulation is eye drops, with the dosage being one drop in the affected eye each time, twice a day (morning and evening), for 3 consecutive days. The purpose of this trial is to evaluate the efficacy and safety of azithromycin eye drops in treating bacterial conjunctivitis, providing clinical data support for the marketing application of azithromycin eye drops.

Azithromycin Eye Drops is a chemical drug, indicated for purulent bacterial conjunctivitis. It is a conjunctival inflammation caused by bacterial infection, with symptoms such as eye redness and increased eye discharge. Diagnosis is mainly based on symptoms and eye examination.

The primary endpoint indicators of this trial include the clinical cure rate of the study eye (clinical cure rate = number of clinically cured cases / number of eligible cases × 100%); secondary endpoint indicators include the bacterial clearance rate of the study eye, the clearance rate of each major pathogenic bacterium, and the clinical cure rate of the study eye at Visit 2 (Day 3).

Currently, the experiment status is ongoing (not yet recruiting).

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Editor: Xiaolang Express