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

NCT06212973 | Completed Phase 3

• 1 other identifier: ZKO-EPI-202111
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes from baseline (Day 0) in independent investigator-rated ocular itch scores

  Changes from baseline (Day 0) in independent investigator-rated ocular itch scores were assessed at visit 5 (Day 14±2) (study eye). The ocular itch score was graded from 0 to 3(0=none, 1=mild, 2=moderate, 3=severe)

  Day 0~Day 14

Secondary Outcomes (1)

• Changes from baseline (Day 0) in independent investigator-rated total score of ocular itch, conjunctival hyperemia, and tearing total score

  Day 0~Day 14

Study Arms (2)

Epinastine hydrochloride eye drops group

EXPERIMENTAL

Administered Epinastine hydrochloride eye drops+Simulating Azelastine hydrochloride eye drops bilaterally, twice daily

Drug: Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln

Azelastine hydrochloride eye drops group

ACTIVE COMPARATOR

Administered Azelastine hydrochloride eye drops+Simulating Epinastine hydrochloride eye drops bilaterally, twice daily

Drug: Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln

Interventions

Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln DRUG

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.

Epinastine hydrochloride eye drops group

Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln DRUG

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.

Azelastine hydrochloride eye drops group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);
• Presence of a systemic disease at the time of screening that may affect the results of the study, e.g., dry syndrome, rheumatoid arthritis, graft-versus-host disease, systemic lupus erythematosus, scleroderma, and tuberculosis;
• Presence of severe, unstable, or uncontrolled cardiovascular, cerebral, pulmonary, hepatic, renal, autoimmune, and other relevant systemic diseases at the time of screening, e.g., severe chronic obstructive pulmonary disease (COPD), severe asthma, severe cardiac arrhythmia, significant heart failure (New York Heart Association classification ≥ Class III), uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 90 mmHg ), uncontrolled diabetes, etc;
• History of medical conditions that, in the judgment of the investigator, may interfere with the safe administration of topical antihistamines/mast cell stabilizers, such as hepatic or renal impairment (ALanine aminoTransferase(ALT) or ASpartate aminoTransferase(AST) ≥ 2.5 times the upper limit of normal; total bilirubin ≥ 1.5 times the upper limit of normal; and serum creatinine or urea/urea nitrogen ≥ 1.2 times the upper limit of normal), in the 6 months prior to screening;
• The following topical (ophthalmic) prohibited drugs have been used or are planned to be used during the study period within the time period specified prior to randomization (the number of days is the pre-randomization period of prohibition and does not include experimental drugs):
• Ocular immunosuppressive drugs (e.g. cyclosporine, tacrolimus, etc.): 60 days;
• Ocular corticosteroid drugs (dexamethasone, flumethasone, prednisone acetate, rimexolone, difluprednate, loteprednol, etc.): 45 days;
• Ocular mast cell stabilizing drugs: 14 days;

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 19, 2024
• Study Start: March 13, 2023
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)