Bimatoprost Ocular Insert Pharmacokinetic Study

NCT02444767 | Completed Phase 1

• 1 other identifier: FSV5-006
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. This study will evaluate the pharmacokinetic aspects of the Bimatoprost Ocular Insert in healthy (non-glaucoma) subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Study Arms (1)

13mg Bimatoprost Insert

EXPERIMENTAL

Subjects in this arm have 13mg Bimatoprost Ocular Inserts placed in both eyes for 7 days.

Drug: 13mg Bimatoprost Ocular Insert

Interventions

13mg Bimatoprost Ocular Insert DRUG

13mg Bimatoprost Ocular Insert in each eye.

13mg Bimatoprost Insert

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ForSight Vision5, Inc.: lead

Study Sites (1)

Sall Medical Research Center

Artesia, California, 90701, United States

Location

Study Officials

• Gary Walker, PhD

  ForSight Vision 5

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

US (1)