Trials Sponsors Conditions Drugs Pricing

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 SolnDrug

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 SolnDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Grouped treatment entry
Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (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;

Sponsors & Collaborators

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Industrylead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Enrollment

266 participants (actual enrollment reported by the registry).

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

Actual (reported)

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;
+22 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Epinastine hydrochloride eye drops group

Azelastine hydrochloride eye drops group

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Epinastine hydrochloride eye drops group

Azelastine hydrochloride eye drops group

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations