HealthyPhase 1NCT05138861
A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects
A Phase 1 study testing TP-03 (Lotilaner Ophthalmic Solution), 0.25% in people with Healthy, run by Tarsus Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration. 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?
- TP-03 (Lotilaner Ophthalmic Solution), 0.25%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 9 Feb 2021to 3 Sep 2021
- 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
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy adult male or female
- If female, meets one of the following criteria:
- Is of childbearing potential and agrees to use an acceptable contraceptive method.
- Or
Show all 11Show fewer
- Male partner has had a vasectomy less than 6 months prior to dosing and the female subject agrees to use an additional acceptable contraceptive method from the first study drug administration until 112 days after the last study drug administration Or
- Is of non-childbearing potential, defined as surgically sterile (ie, has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a post-menopausal state (ie, at least 1 year without menses without an alternative medical condition prior to the first study drug administration)
- Aged at least 18 years
- Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration)
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator
Who cannot join
- Female who is lactating
- Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration
- Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the 28 days prior to the first study drug administration
Show all 17Show fewer
- Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration
- Use of St. John's wort in the 28 days prior to the first study drug administration
- History of any ocular surgery or laser within the past 12 months prior to the first study drug administration
- Have used artificial eyelashes, eyelash extensions or had other cosmetic eyelash or eyelid procedures (e.g., eyeliner tattooing, eyelash tinting, eyelash curling perm, etc.) within 7 days prior to Screening or unwilling to forego their use during the study
- Presence of clinically significant ocular surface diseases including blepharitis, dry eye, corneal scars, and pterygium, or any ocular abnormalities identified at Screening
- Presence of acute ocular infection or inflammation at Screening, or required use of eye drops
- Any history of tuberculosis
- Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests
- Intake of an Investigational Product (IP) in the 28 days prior to the first study drug administration
- Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration
Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration.
Read the detailed description
This is a single-center, open-label, single-arm study. A single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 1 and then twice a day (in the morning and in the evening, approximately 12 hours apart) starting on Day 2 for 40 consecutive days (Days 2 to 41). Thereafter, a single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 42, for a total of 82 consecutive doses administered in each eye. The doses of Days 1, 2 (morning), 41 (evening), and 42 will be self-administered under supervision of the site staff at the clinical site. All remaining doses will be self-administered at home. Throughout the study, PK blood samples will be collected and safety assessments will be performed.
- Conditions
- Healthy
- Being tested
- TP-03 (Lotilaner Ophthalmic Solution), 0.25%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-03 (Lotilaner Ophthalmic Solution), 0.25%Drug
A single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 1 and then twice a day (in the morning and in the evening, approximately 12 hours apart) starting on Day 2 for 40 consecutive days (Days 2 to 41). Thereafter, a single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 42, for a total of 82 consecutive doses administered in each eye.
| Study group | Role | What they receive |
|---|---|---|
| TP-03 (Lotilaner Ophthalmic Solution), 0.25% | Experimental | TP-03, topical ocular administration in healthy adults. Single and multiple doses for 42 days. Receives: Drug: TP-03 (Lotilaner Ophthalmic Solution), 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Cmax at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Tmax at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Tlag at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-168 at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-2880 at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-t at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-inf at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner CL/F at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Vz/F at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner eff at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Thalf at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner λz at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC%extrap at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner MRT0-t at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Rac at various times
Measured: 42 Days
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Ctrough at various times
Measured: 42 Days
Incidence of treatment emergent adverse events (TEAEs)
Safety will be evaluated through the incidence rate of TEAEs
Measured: 42 Days
Clinically significant changes from Baseline chemistry laboratory tests
Evaluate the safety of TP-03 through clinically significant changes from Baseline chemistry laboratory tests
Measured: 42 Days
Clinically significant changes from Baseline hematology laboratory tests
Evaluate the safety of TP-03 through clinically significant changes from Baseline hematology laboratory tests
Measured: 42 Days
Clinically significant changes from Baseline physical examinations
Safety will be evaluated through review of clinically significant changes in physical examinations from Baseline
Measured: 42 Days
Clinically significant changes from Baseline electrocardiograms (ECGs)
Safety will be evaluated through review of clinically significant changes in electrocardiograms from Baseline
Measured: 42 Days
Clinically significant changes from Baseline vitals
Safety will be evaluated through review of clinically significant changes from Baseline vital signs (including temperature [degrees Celsius], pulse rate [beats per minute], respiration rate [breaths per minute], and changes in systolic and diastolic blood pressure [mmHg]) from Baseline
Measured: 42 Days
Clinically significant changes from Baseline corrected distance visual acuity
Safety will be evaluated through review of clinically significant changes in corrected distance visual acuity from Baseline
Measured: 42 Days
Clinically significant changes from Baseline non-mydriatic fundus photographs
Safety will be evaluated through review of clinically significant changes in non-mydriatic fundus photographs from Baseline
Measured: 42 Days
Clinically significant changes from Baseline intraocular pressure (IOP) measurement
Safety will be evaluated through review of clinically significant changes in IOP from Baseline
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start9 Feb 2021
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, open-label, single-arm study.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Holdbrook, Study director, Tarsus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138861
- Sponsor's protocol ID
- TRS-012
- Status last verified
- Apr 2024
- First submitted
- 22 Jul 2021
- Last updated
- 12 Apr 2024
- 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration
- ClinicalTrials.gov ID
- NCT05138861
- Acronym / sponsor ID
- TRS-012
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 1 Dec 2021 (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.
Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration.
Detailed description
This is a single-center, open-label, single-arm study. A single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 1 and then twice a day (in the morning and in the evening, approximately 12 hours apart) starting on Day 2 for 40 consecutive days (Days 2 to 41). Thereafter, a single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 42, for a total of 82 consecutive doses administered in each eye. The doses of Days 1, 2 (morning), 41 (evening), and 42 will be self-administered under supervision of the site staff at the clinical site. All remaining doses will be self-administered at home. Throughout the study, PK blood samples will be collected and safety assessments will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, open-label, single-arm study.
| Arm | Type | Receives |
|---|---|---|
| TP-03 (Lotilaner Ophthalmic Solution), 0.25% | Experimental | Drug: TP-03 (Lotilaner Ophthalmic Solution), 0.25%TP-03, topical ocular administration in healthy adults. Single and multiple doses for 42 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy adult male or female
- If female, meets one of the following criteria:
- Or
Key exclusion criteria (17 listed)
- Female who is lactating
- Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration
- Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
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 |
|---|---|---|
| TP-03 (Lotilaner Ophthalmic Solution), 0.25%A single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 1 and then twice a day (in the morning and in the evening, approximately 12 hours apart) starting on Day 2 for 40 consecutive days (Days 2 to 41). Thereafter, a single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 42, for a total of 82 consecutive doses administered in each eye. | Drug | TP-03 (Lotilaner Ophthalmic Solution), 0.25% |
Primary outcome
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Cmax at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Tmax at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Tlag at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-168 at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-2880 at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-t at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-inf at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner CL/F at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Vz/F at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner eff at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Thalf at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner λz at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC%extrap at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner MRT0-t at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Rac at various times
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.
Time frame: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Ctrough at various times
Incidence of treatment emergent adverse events (TEAEs)
Time frame: 42 Days
Safety will be evaluated through the incidence rate of TEAEs
Clinically significant changes from Baseline chemistry laboratory tests
Time frame: 42 Days
Evaluate the safety of TP-03 through clinically significant changes from Baseline chemistry laboratory tests
Clinically significant changes from Baseline hematology laboratory tests
Time frame: 42 Days
Evaluate the safety of TP-03 through clinically significant changes from Baseline hematology laboratory tests
Clinically significant changes from Baseline physical examinations
Time frame: 42 Days
Safety will be evaluated through review of clinically significant changes in physical examinations from Baseline
Clinically significant changes from Baseline electrocardiograms (ECGs)
Time frame: 42 Days
Safety will be evaluated through review of clinically significant changes in electrocardiograms from Baseline
Clinically significant changes from Baseline vitals
Time frame: 42 Days
Safety will be evaluated through review of clinically significant changes from Baseline vital signs (including temperature [degrees Celsius], pulse rate [beats per minute], respiration rate [breaths per minute], and changes in systolic and diastolic blood pressure [mmHg]) from Baseline
Clinically significant changes from Baseline corrected distance visual acuity
Time frame: 42 Days
Safety will be evaluated through review of clinically significant changes in corrected distance visual acuity from Baseline
Clinically significant changes from Baseline non-mydriatic fundus photographs
Time frame: 42 Days
Safety will be evaluated through review of clinically significant changes in non-mydriatic fundus photographs from Baseline
Clinically significant changes from Baseline intraocular pressure (IOP) measurement
Time frame: 42 Days
Safety will be evaluated through review of clinically significant changes in IOP from Baseline
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 12 Apr 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.
Mark Holdbrook study director
Tarsus Pharmaceuticals
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 TP-03 (Lotilaner Ophthalmic Solution), 0.25% in people with Healthy, run by Tarsus Pharmaceuticals, Inc. at 1 site in Canada.
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 11 inclusion and 17 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 12 Apr 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 Canada. 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?
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. (time frame: 42 Days). The study lists 25 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 12 Apr 2024.