Bimatoprost Ocular Insert Pharmacokinetic Study

May 13, 2015 updated by: ForSight Vision5, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Artesia, California, United States, 90701
        • Sall Medical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects between the ages of 18 and 55 years, inclusive.
  2. Subjects who are medically stable with or without POAG or OHT.
  3. Written informed consent to participate in the study.
  4. Body mass index between 18 and 30 kg/m², inclusive.
  5. 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).

Exclusion Criteria:

  1. 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.
  2. A history of allergic or adverse responses to bimatoprost or any comparable or similar product.
  3. Subjects who are unable to tolerate the Inserts that do not contain drug for the 7 days trial wear period.
  4. 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.
  5. Subjects who will require contact lens use during the study period.
  6. Subjects who currently have punctal occlusion in one or both eyes.
  7. Subjects who have made a blood donation of one (1) pint or more within 30 days prior to study initiation.
  8. Subjects who have made a plasma donation within 14 days of study initiation.
  9. Participation in a clinical trial within 30 days prior to the first dose of Study Drug.
  10. Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and dietary supplements, during the study.
  11. Use of any prescription medication during the medication washout (screening) period or during the study.
  12. Required use during study of ocular medications or artificial tears.
  13. Ocular, orbital, and/or eyelid surgery of any type within the past 6 months from screening date.
  14. Past history of incisional surgery for glaucoma at any time.
  15. Past history of corneal refractive surgery.
  16. 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.
  17. Smoking or use of tobacco products or products containing nicotine within 6 months prior to or during the study.
  18. Female subjects who are lactating.
  19. Positive pregnancy test prior to administration of Study Insert for all women of childbearing potential.
  20. Positive urine screen for alcohol, drugs of abuse, or cotinine.
  21. 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.
  22. 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.
  23. Subjects who were on ocular hypotensive treatment who are not fully washed out prior to receiving active inserts.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 13mg Bimatoprost Insert
Subjects in this arm have 13mg Bimatoprost Ocular Inserts placed in both eyes for 7 days.
Drug: 13mg Bimatoprost Ocular Insert
13mg Bimatoprost Ocular Insert in each eye.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ForSight Vision5, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gary Walker, PhD, ForSight Vision 5

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FSV5-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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