Healthy VolunteersPhase 1NCT02444767
Bimatoprost Ocular Insert Pharmacokinetic Study
A Phase 1 study testing 13mg Bimatoprost Ocular Insert in people with Healthy Volunteers, run by ForSight Vision5, Inc. at 1 site in United States.
Trial summary
The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 13mg Bimatoprost Ocular Insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Apr 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects between the ages of 18 and 55 years, inclusive.
- Subjects who are medically stable with or without POAG or OHT.
- Written informed consent to participate in the study.
- Body mass index between 18 and 30 kg/m², inclusive.
- Female subjects of childbearing potential - not surgically sterile or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, intrauterine device or vasectomized partner (6 months minimum).
Who cannot join
- A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- A history of allergic or adverse responses to bimatoprost or any comparable or similar product.
- Subjects who are unable to tolerate the Inserts that do not contain drug for the 7 days trial wear period.
- Subjects who require two (2) or more site-assisted replacements of the inserts that do not contain drug during the 7 days trial wear period.
- Subjects who will require contact lens use during the study period.
- Subjects who currently have punctal occlusion in one or both eyes.
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- Subjects who have made a blood donation of one (1) pint or more within 30 days prior to study initiation.
- Subjects who have made a plasma donation within 14 days of study initiation.
- Participation in a clinical trial within 30 days prior to the first dose of Study Drug.
- Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and dietary supplements, during the study.
- Use of any prescription medication during the medication washout (screening) period or during the study.
- Required use during study of ocular medications or artificial tears.
- Ocular, orbital, and/or eyelid surgery of any type within the past 6 months from screening date.
- Past history of incisional surgery for glaucoma at any time.
- Past history of corneal refractive surgery.
- Any active ocular disease that in the opinion of the Investigator would interfere with the conduct of the study (e.g., severe dry eye, uveitis, inflammation, ocular infection, corneal edema). Patients may have mild blepharitis, mild dry eye, cataracts, age-related macular degeneration or background diabetic retinopathy if, in the opinion of the Investigator, it would not interfere with the conduct of the study.
- Smoking or use of tobacco products or products containing nicotine within 6 months prior to or during the study.
- Female subjects who are lactating.
- Positive pregnancy test prior to administration of Study Insert for all women of childbearing potential.
- Positive urine screen for alcohol, drugs of abuse, or cotinine.
- Subjects with POAG or OHT for whom, in the opinion of the investigator, it would be unsafe to discontinue ocular hypotensive treatment for the required periods during the study.
- Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than grade 2 based on gonioscopy performed within the last 12 months.
- Subjects who were on ocular hypotensive treatment who are not fully washed out prior to receiving active inserts.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sall Medical Research Center
Artesia, California, 90701
About this study
Official title: A PK Study to Assess the Relative Systemic Exposure to Bimatoprost and Bimatoprost Acid After Administration of a Single 13 mg Bimatoprost Ocular Insert for 1 Week in Medically Stable Adult Subjects With or Without Open-Angle Glaucoma or Ocular Hypertension
The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
This study will evaluate the pharmacokinetic aspects of the Bimatoprost Ocular Insert in healthy (non-glaucoma) subjects.
Read the detailed description
This study is designed to provide pharmacokinetic (PK) data with respect to the relative systemic exposure to bimatoprost and bimatoprost acid after administration of a single 13 mg Bimatoprost Ocular Insert for 1 week in medically stable adult subjects with or without primary open angle glaucoma (POAG) or ocular hypertension (OHT).
- Conditions
- Healthy Volunteers
- Being tested
- 13mg Bimatoprost Ocular Insert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13mg Bimatoprost Ocular InsertDrug
13mg Bimatoprost Ocular Insert in each eye.
| Study group | Role | What they receive |
|---|---|---|
| 13mg Bimatoprost Insert | Experimental | Subjects in this arm have 13mg Bimatoprost Ocular Inserts placed in both eyes for 7 days. Receives: Drug: 13mg Bimatoprost Ocular Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole blood concentrations of bimatoprost and bimatoprost acid
Whole blood concentrations of bimatoprost and bimatoprost acid will be measured using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- ForSight Vision5, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Walker, PhD, Study director, ForSight Vision 5
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444767
- Sponsor's protocol ID
- FSV5-006
- Status last verified
- May 2015
- First submitted
- 12 May 2015
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PK Study to Assess the Relative Systemic Exposure to Bimatoprost and Bimatoprost Acid After Administration of a Single 13 mg Bimatoprost Ocular Insert for 1 Week in Medically Stable Adult Subjects With or Without Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02444767
- Acronym / sponsor ID
- FSV5-006
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- ForSight Vision5, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 May 2015 (estimated)
- 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 Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
This study will evaluate the pharmacokinetic aspects of the Bimatoprost Ocular Insert in healthy (non-glaucoma) subjects.
Detailed description
This study is designed to provide pharmacokinetic (PK) data with respect to the relative systemic exposure to bimatoprost and bimatoprost acid after administration of a single 13 mg Bimatoprost Ocular Insert for 1 week in medically stable adult subjects with or without primary open angle glaucoma (POAG) or ocular hypertension (OHT).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 13mg Bimatoprost Insert | Experimental | Drug: 13mg Bimatoprost Ocular InsertSubjects in this arm have 13mg Bimatoprost Ocular Inserts placed in both eyes for 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female subjects between the ages of 18 and 55 years, inclusive.
- Subjects who are medically stable with or without POAG or OHT.
- Written informed consent to participate in the study.
- Body mass index between 18 and 30 kg/m², inclusive.
- Female subjects of childbearing potential - not surgically sterile or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, intrauterine device or vasectomized partner (6 months minimum).
Key exclusion criteria (23 listed)
- A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- A history of allergic or adverse responses to bimatoprost or any comparable or similar product.
- Subjects who are unable to tolerate the Inserts that do not contain drug for the 7 days trial wear period.
- Subjects who require two (2) or more site-assisted replacements of the inserts that do not contain drug during the 7 days trial wear period.
- Subjects who will require contact lens use during the study period.
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 |
|---|---|---|
| 13mg Bimatoprost Ocular Insert13mg Bimatoprost Ocular Insert in each eye. | Drug | 13mg Bimatoprost Insert |
Primary outcome
Whole blood concentrations of bimatoprost and bimatoprost acid
Time frame: 7 days
Whole blood concentrations of bimatoprost and bimatoprost acid will be measured using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method.
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 14 May 2015.
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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.
Gary Walker, PhD study director
ForSight Vision 5
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 13mg Bimatoprost Ocular Insert in people with Healthy Volunteers, run by ForSight Vision5, Inc. 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 23 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 14 May 2015. 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?
Whole blood concentrations of bimatoprost and bimatoprost acid (time frame: 7 days). 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 14 May 2015.