Seasonal Allergic ConjunctivitisPhase 3NCT06212973
A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients
A Phase 3 study testing Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln and Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln in people with Seasonal Allergic Conjunctivitis, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seasonal Allergic Conjunctivitis
- What is being tested?
- Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln and Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2023to 2 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Ocular antihistamine and decongestant drugs: 3 days;
- Ocular artificial tears: 1 day;
- Other ophthalmic drugs: 3 days.
- 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.
- 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.
- 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;
- Known allergic reaction to epinastine hydrochloride eye drops, azelastine hydrochloride eye drops, or any of the components of the simulated medications;
- inability to avoid wearing contact lenses for the duration of the study;
- participation in another clinical research trial within 30 days prior to randomization or planned during the study period;
- 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;
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-masked, Active Controlled Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops 0.05% in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients
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
- Being tested
- Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln, Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph SolnDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Epinastine hydrochloride eye drops group | Experimental | Administered Epinastine hydrochloride eye drops+Simulating Azelastine hydrochloride eye drops bilaterally, twice daily Receives: 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 Receives: Drug: Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Changes from baseline (Day 0) in independent investigator-rated total score of ocular itch, conjunctival hyperemia, and tearing total score 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)
Measured: Day 0~Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start13 Mar 2023
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212973
- Sponsor's protocol ID
- ZKO-EPI-202111
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-masked, Active Controlled Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops 0.05% in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients
- ClinicalTrials.gov ID
- NCT06212973
- Acronym / sponsor ID
- ZKO-EPI-202111
- Conditions
- Seasonal Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinastine hydrochloride eye drops group | Experimental | Drug: Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph SolnAdministered Epinastine hydrochloride eye drops+Simulating Azelastine hydrochloride eye drops bilaterally, twice daily |
| Azelastine hydrochloride eye drops group | Active comparator | Drug: Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph SolnAdministered Azelastine hydrochloride eye drops+Simulating Epinastine hydrochloride eye drops bilaterally, twice daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Clinician-diagnosed seasonal allergic conjunctivitis in both eyes based on history, symptoms, and signs.
Key exclusion criteria (37 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph SolnEpinastine 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. | Drug | Epinastine hydrochloride eye drops group |
| Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph SolnAzelastine 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. | Drug | Azelastine hydrochloride eye drops group |
Primary outcome
Changes from baseline (Day 0) in independent investigator-rated ocular itch scores
Time frame: Day 0~Day 14
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)
1 secondary outcome
Changes from baseline (Day 0) in independent investigator-rated total score of ocular itch, conjunctival hyperemia, and tearing total score
Time frame: Day 0~Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln and Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln in people with Seasonal Allergic Conjunctivitis, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline (Day 0) in independent investigator-rated ocular itch scores (time frame: Day 0~Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.