| Eligibility |
Inclusion Criteria:
1. 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;
2. The age on the date of signing the informed consent is equal to or greater than 12
years old, gender is not limited;
3. Have any one of the following three laboratory report records prior to randomization:
1. Positive eosinophil cytology results;
2. Positive specific immunoglobulin E (IgE) test;
3. Positive skin prick test;
4. Clinician-diagnosed seasonal allergic conjunctivitis in both eyes based on history,
symptoms, and signs.
Exclusion Criteria:
1. 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;
2. 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;
3. Best corrected visual acuity (BCVA) of less than 4.4 (five-point visual acuity) in
either eye at screening;
4. Intraocular pressure>21 mmHg or <8 mmHg in either eye at screening;
5. Current or previous glaucoma or other optic nerve disease, or suspected glaucoma and
other optic nerve disease, in either eye;
6. current or previous retinal detachment, diabetic retinopathy, or the presence of any
progressive retinal disease in either eye;
7. 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;
8. 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);
9. 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;
10. 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;
11. 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;
12. 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;
- Ocular antihistamine and decongestant drugs: 3 days;
- Ocular artificial tears: 1 day;
- Other ophthalmic drugs: 3 days.
13. The following topical (dermal or nasal spray) prohibited medications have been used
for the time specified prior to randomization or are planned to be used for the
duration of the study (the number of days is the duration of prohibition prior to
randomization):
- Antihistamines and corticosteroids for periocular skin: 7 days;
- Nasal spray immunosuppressive drugs: 60 days;
- Nasal spray corticosteroid drugs: 45 days;
- Nasal spray mast cell stabilizing drug: 14 days;
- Nasal spray antihistamine and decongestant drugs: 3 days.
14. The following systemically 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 time of prohibition prior to randomization):
- Immunotherapy and immunosuppressive agents (including biologics): 60 days;
- Long-acting corticosteroids (dexamethasone, betamethasone): 30 days;
- Leukotriene receptor antagonists (e.g., montelukast sodium): 30 days;
- Non-long-acting corticosteroids, mast cell stabilizers: 14 days;
- Antihistamines, decongestants, monoamine oxidase inhibitors: 7 days;
- Aspirin-containing drugs, non-steroidal anti-inflammatory drugs(NSAIDs): 3 days.
15. Non-pharmacological treatments to reduce the signs or symptoms of seasonal allergic
conjunctivitis such as cold compresses to the eyes, desensitization therapy, and
saline rinsing of the eyes are planned for the duration of the study;
16. Known allergic reaction to epinastine hydrochloride eye drops, azelastine
hydrochloride eye drops, or any of the components of the simulated medications;
17. inability to avoid wearing contact lenses for the duration of the study;
18. participation in another clinical research trial within 30 days prior to randomization
or planned during the study period;
19. women who are pregnant or breastfeeding; subjects who have a positive pregnancy test
result at screening; do not consent to the use of an effective method of contraception
from the start of the study until 4 weeks after the end of the study (including
hormonal methods - oral, implanted, injectable, or transdermal birth control pills;
physical barrier methods - - spermicide in combination with a physical barrier method
such as a diaphragm or condom; an intrauterine device; or surgical sterilization of a
partner, etc.) to avoid pregnancy in themselves or their partner within 4 weeks of
study start to study end for subjects of childbearing age;
20. Presence of other factors that, in the opinion of the investigator, make participation
in this study inappropriate, including inability or unwillingness to comply with the
protocol (e.g., alcoholism, drug dependence, or psychological disorders, etc.).
|
