HealthyPhase 1NCT03098953
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations
A Phase 1 study testing Loteprednol Etabonate in people with Healthy, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Loteprednol Etabonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2017to 12 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are able to read, understand and provide written informed consent on an Informed Consent Form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- Be a non-smoking male or female at least 18 years of age on the date the ICF is signed and with the capacity to provide voluntary informed consent.
- Be in general good health and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or place the subject at increased risk during the study.
- Be willing/able to return for all required study visits and follow instructions from the study Investigator and his/her staff.
- Are able to self-administer eye drops or have a clinical staff member deliver the single dose of investigational product (IP) on specified study days.
Who cannot join
- Have a history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject, confound the result(s) of the study, or preclude study treatment or follow-up.
- Have any current disease or medical condition that requires medicinal therapy.
- Have a history of drug or alcohol abuse in the last 6 months.
- Have a positive urine screen for alcohol, amphetamines, barbiturates, benzodiazepines, cocaine (or cocaine metabolite), cannabinoids, methadone, methamphetamine, opiates and/or phencyclidine.
- Are known to have a prior positive blood screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus types 1 and 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of LE Ophthalmic Gel
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel
Read the detailed description
This will be a single-center, single-arm, open label PK clinical study of loteprednol etabonate (LE) ophthalmic gel, 0.38% conducted at one clinical center in the United States (US), with the goal of enrolling approximately 15 healthy normal subjects in the treatment period
- Conditions
- Healthy
- Being tested
- Loteprednol Etabonate
- Keywords
- Ocular Installation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol EtabonateDrug
Also called LE gel
one drop per eye for each eye
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel | Experimental | one drop per eye for each eye Receives: Drug: Loteprednol Etabonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK analysis will be performed using standard non compartmental method
When possible, plasma concentrations by scheduled time point and PK parameters (AUC0-t (Area under the time-concentration curve to the last measured time point) will be summarized using descriptive statistics by Visit.
Measured: Day15/Day1
PK analysis will be performed using standard non compartmental method
When possible, plasma concentrations by scheduled time point and PK parameters, AUC0-∞(Area under the time-concentration curve extrapolated to infinity) will be summarized using descriptive statistics by Visit.
Measured: Day 15/Day 1
PK analysis will be performed using standard non compartmental method
When possible, plasma concentrations by scheduled time point and PK parameters Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit.
Measured: Day15/Day1
PK analysis will be performed using standard non compartmental method
When possible, plasma concentrations by scheduled time point and PK parameters Cmax (Maximum drug plasma concentration), Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit.
Measured: Day15/Day1
PK analysis will be performed using standard non compartmental method
When possible, plasma concentrations by scheduled time point and PK parameters RAUC (Ratio (Visit 3/Visit 2) for AUC0-t) will be summarized using descriptive statistics by Visit.
Measured: Day15/Day1
PK analysis will be performed using standard non compartmental method
When possible, plasma concentrations by scheduled time point and PK parameters RCmax (Ratio (Visit 3/Visit 2) for Cmax) will be summarized using descriptive statistics by Visit.
Measured: Day15/Day1
PK analysis will be performed using standard non compartmental method
When possible, plasma concentrations by scheduled time point and PK parameters Tmax (Time at which maximum plasma concentration achieved) will be summarized using descriptive statistics by Visit.
Measured: Day15/Day1
PK analysis will be performed using standard non compartmental method
When possible, plasma concentrations by scheduled time point and PK parameters Kel (Elimination rate constant) will be summarized using descriptive statistics by Visit.
Measured: Day15/Day1
PK analysis will be performed using standard non compartmental method
When possible, plasma concentrations by scheduled time point and PK parameters T1/2 (Plasma drug concentration half-life)) will be summarized using descriptive statistics by Visit
Measured: Day 15/Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start10 Apr 2017
- Primary completion12 May 2017
- Study completion12 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098953
- Sponsor's protocol ID
- 881
- Status last verified
- May 2017
- First submitted
- 20 Mar 2017
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of LE Ophthalmic Gel
- ClinicalTrials.gov ID
- NCT03098953
- Acronym / sponsor ID
- 881
- Conditions
- Healthy
- Keywords
- Ocular Installation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 12 May 2017 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 4 Apr 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.
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel
Detailed description
This will be a single-center, single-arm, open label PK clinical study of loteprednol etabonate (LE) ophthalmic gel, 0.38% conducted at one clinical center in the United States (US), with the goal of enrolling approximately 15 healthy normal subjects in the treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel | Experimental | Drug: Loteprednol Etabonateone drop per eye for each eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are able to read, understand and provide written informed consent on an Informed Consent Form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- Be a non-smoking male or female at least 18 years of age on the date the ICF is signed and with the capacity to provide voluntary informed consent.
- Be in general good health and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or place the subject at increased risk during the study.
- Be willing/able to return for all required study visits and follow instructions from the study Investigator and his/her staff.
- Are able to self-administer eye drops or have a clinical staff member deliver the single dose of investigational product (IP) on specified study days.
Key exclusion criteria (5 listed)
- Have a history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject, confound the result(s) of the study, or preclude study treatment or follow-up.
- Have any current disease or medical condition that requires medicinal therapy.
- Have a history of drug or alcohol abuse in the last 6 months.
- Have a positive urine screen for alcohol, amphetamines, barbiturates, benzodiazepines, cocaine (or cocaine metabolite), cannabinoids, methadone, methamphetamine, opiates and/or phencyclidine.
- Are known to have a prior positive blood screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus types 1 and 2.
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 |
|---|---|---|
| Loteprednol EtabonateAlso: LE gelone drop per eye for each eye | Drug | Loteprednol Etabonate Ophthalmic Gel |
Primary outcome
PK analysis will be performed using standard non compartmental method
Time frame: Day15/Day1
When possible, plasma concentrations by scheduled time point and PK parameters (AUC0-t (Area under the time-concentration curve to the last measured time point) will be summarized using descriptive statistics by Visit.
PK analysis will be performed using standard non compartmental method
Time frame: Day 15/Day 1
When possible, plasma concentrations by scheduled time point and PK parameters, AUC0-∞(Area under the time-concentration curve extrapolated to infinity) will be summarized using descriptive statistics by Visit.
PK analysis will be performed using standard non compartmental method
Time frame: Day15/Day1
When possible, plasma concentrations by scheduled time point and PK parameters Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit.
PK analysis will be performed using standard non compartmental method
Time frame: Day15/Day1
When possible, plasma concentrations by scheduled time point and PK parameters Cmax (Maximum drug plasma concentration), Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit.
PK analysis will be performed using standard non compartmental method
Time frame: Day15/Day1
When possible, plasma concentrations by scheduled time point and PK parameters RAUC (Ratio (Visit 3/Visit 2) for AUC0-t) will be summarized using descriptive statistics by Visit.
PK analysis will be performed using standard non compartmental method
Time frame: Day15/Day1
When possible, plasma concentrations by scheduled time point and PK parameters RCmax (Ratio (Visit 3/Visit 2) for Cmax) will be summarized using descriptive statistics by Visit.
PK analysis will be performed using standard non compartmental method
Time frame: Day15/Day1
When possible, plasma concentrations by scheduled time point and PK parameters Tmax (Time at which maximum plasma concentration achieved) will be summarized using descriptive statistics by Visit.
PK analysis will be performed using standard non compartmental method
Time frame: Day15/Day1
When possible, plasma concentrations by scheduled time point and PK parameters Kel (Elimination rate constant) will be summarized using descriptive statistics by Visit.
PK analysis will be performed using standard non compartmental method
Time frame: Day 15/Day 1
When possible, plasma concentrations by scheduled time point and PK parameters T1/2 (Plasma drug concentration half-life)) will be summarized using descriptive statistics by Visit
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 18 May 2017.
- Individual participant dataSharing planned: Yes
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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.
Anya Loncaric study director
Bausch Health Americas, Inc.
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 Loteprednol Etabonate in people with Healthy, run by Bausch & Lomb Incorporated at 1 site in United States.
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 5 inclusion and 5 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 18 May 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 United States. 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?
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?
PK analysis will be performed using standard non compartmental method (time frame: Day15/Day1). The study lists 9 primary outcomes in all. 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 18 May 2017.