Bacterial ConjunctivitisPhase 1NCT03235141
Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
A Phase 1 study testing azithromycin eye drops by essex and azithromycin eye drops in people with Bacterial Conjunctivitis, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the original azithromycin eye drops, and evaluate the release behavior of both in the eye. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Conjunctivitis
- What is being tested?
- azithromycin eye drops by essex and azithromycin eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2017to 30 Dec 2017
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years old, male or female;
- BMI in the range of 19 to 28;
- eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal;
- Good compliance and voluntarily signed consent.
Who cannot join
- Have eye disease or systemic disease;
- physical examination, laboratory tests, ECG and chest X-ray examination abnormalities and has clinical significance;
- HBsAg, anti-HCV and HIV positive;
- those who used eye drops two weeks before the test and who used any dosage form of azithromycin;
- known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions;
- need to wear contact lenses during the test;
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- history of internal surgery or laser surgery history;
- participated in other drug clinical trials in the past three months;
- pregnant women and lactating women, or in the growth period without taking effective contraceptive measures, menstrual period women;
- mental illness or alcohol, history of drug abuse or inability to collaborate;
- Any other circumstances that the investigators consider are unfit to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100005
Feng Wu, 010-58268422, trdrug@126.com
About this study
To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the original azithromycin eye drops, and evaluate the release behavior of both in the eye.
Read the detailed description
There are 48 patients will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.
- Conditions
- Bacterial Conjunctivitis
- Being tested
- azithromycin eye drops by essex, azithromycin eye drops
- Keywords
- Azithromycin eye drops, Local Pharmacokinetics
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycin eye drops by essexDrug
azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),
azithromycin eye dropsDrug
Also called AzaSite
azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc
| Study group | Role | What they receive |
|---|---|---|
| azithromycin eye drops by essex | Experimental | In one cycle, give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the AzaSite eye drops,2.5ml/25mg，1 drop，once. Receives: Drug: azithromycin eye drops by essex; Drug: azithromycin eye drops |
| AzaSite | Active comparator | In one cycle, give the AzaSite eye drops,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once. Receives: Drug: azithromycin eye drops by essex; Drug: azithromycin eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The AUC of the test drug and the control drug was calculated at the average concentration of each point
Measured: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
Secondary outcomes (3)
Cmax
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The Cmax of the test drug and the control drug was calculated at the average concentration of each point
Measured: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
AE
compared the laboratory test values before and after treatment,according to the study drug use, calculate the number of cases, the number of cases and the incidence of adverse reactions.
Measured: from the ICF signed to the end of the trial,through study completion, an average of 1 year
SAE
Any serious adverse events that occur during the clinical study, whether or not related to the drug should be collected.
Measured: from the ICF signed to the end of the trial,through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start7 Jul 2017
- Primary completion30 Oct 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial ConjunctivitisStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There are 8 subjects will be enrolled in pre-test, each subject was sampled in two eyes and each subject participated in two cycles of the trial. 8 subjects, 16 eyes participated in the study, 32 samples of tears total . There are 48 subjects will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhuhai Essex Bio-Pharmaceutical Company Limited, Panacea Technologies
- Responsible party
- Principal investigator, Xiuli Zhao, Beijing Tongren Hospital
- Investigators
- Xiuli Zhao, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235141
- Sponsor's protocol ID
- ESSEX-AOS-PK-2001
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03235141
- Acronym / sponsor ID
- ESSEX-AOS-PK-2001
- Conditions
- Bacterial Conjunctivitis
- Keywords
- Azithromycin eye drops, Local Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Zhuhai Essex Bio-Pharmaceutical Company Limited, Panacea Technologies
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 30 Oct 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 1 Aug 2017 (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.
To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the original azithromycin eye drops, and evaluate the release behavior of both in the eye.
Detailed description
There are 48 patients will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- There are 8 subjects will be enrolled in pre-test, each subject was sampled in two eyes and each subject participated in two cycles of the trial. 8 subjects, 16 eyes participated in the study, 32 samples of tears total . There are 48 subjects will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.
| Arm | Type | Receives |
|---|---|---|
| azithromycin eye drops by essex | Experimental | Drug: azithromycin eye drops by essex, Drug: azithromycin eye dropsIn one cycle, give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the AzaSite eye drops,2.5ml/25mg，1 drop，once. |
| AzaSite | Active comparator | Drug: azithromycin eye drops by essex, Drug: azithromycin eye dropsIn one cycle, give the AzaSite eye drops,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 65 years old, male or female;
- BMI in the range of 19 to 28;
- eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal;
- Good compliance and voluntarily signed consent.
Key exclusion criteria (11 listed)
- Have eye disease or systemic disease;
- physical examination, laboratory tests, ECG and chest X-ray examination abnormalities and has clinical significance;
- HBsAg, anti-HCV and HIV positive;
- those who used eye drops two weeks before the test and who used any dosage form of azithromycin;
- known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions;
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 |
|---|---|---|
| azithromycin eye drops by essexazithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL), | Drug | AzaSite, azithromycin eye drops by essex |
| azithromycin eye dropsAlso: AzaSiteazithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc | Drug | AzaSite, azithromycin eye drops by essex |
Primary outcome
AUC0-t
Time frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The AUC of the test drug and the control drug was calculated at the average concentration of each point
3 secondary outcomes
Cmax
Time frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
AE
Time frame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
SAE
Time frame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- 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.
Xiuli Zhao principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing azithromycin eye drops by essex and azithromycin eye drops in people with Bacterial Conjunctivitis, run by Beijing Tongren Hospital 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Aug 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zhao, Doctor (+86-13911901818, XL_Zhao_YLJD@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours). 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 1 Aug 2017.