A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatmen… (NCT06212973) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients
China266 participantsStarted 2023-03-13
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Able to understand and voluntarily sign the informed consent form, and able to comply with the treatment plan, visits, and laboratory tests stipulated in the study. subjects under 18 years of age and without full capacity for civil behavior are required to sign the informed consent form in writing, and a legal guardian is also required to sign the informed consent form;
✓. The age on the date of signing the informed consent is equal to or greater than 12 years old, gender is not limited;
✓. Have any one of the following three laboratory report records prior to randomization:
✓. Positive eosinophil cytology results;
✓. Positive specific immunoglobulin E (IgE) test;
✓. Positive skin prick test;
✓. Clinician-diagnosed seasonal allergic conjunctivitis in both eyes based on history, symptoms, and signs.
Exclusion criteria
✕. Presence of ocular diseases that may affect the study results at the time of screening in either eye, such as blepharitis, blepharitis, dacryoadenitis, dacryocystitis, infectious conjunctivitis, keratitis, moderate-to-severe dry eye (according to the diagnostic grading of the Chinese expert consensus on dry eye), and uveitis;
What they're measuring
1
Changes from baseline (Day 0) in independent investigator-rated ocular itch scores
✕. Conjunctival inflammatory proliferative lesions (including giant papillary hyperplasia, paving stone-like hyperplasia, jelly-like hyperplasia, etc.) within 2 years prior to screening in either eye;
✕. Best corrected visual acuity (BCVA) of less than 4.4 (five-point visual acuity) in either eye at screening;
✕. Intraocular pressure\>21 mmHg or \<8 mmHg in either eye at screening;
✕. Current or previous glaucoma or other optic nerve disease, or suspected glaucoma and other optic nerve disease, in either eye;
✕. current or previous retinal detachment, diabetic retinopathy, or the presence of any progressive retinal disease in either eye;
✕. Either eye has had internal eye surgery within 6 months prior to screening or has had laser eye surgery and external eye surgery within 3 months prior to screening or plans to have eye surgery during the study period;
✕. Ocular trauma within 3 months prior to Screening in either eye (except where, in the judgment of the Investigator, there is no impact on the study validity and safety results);