An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert (OLE2)

An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004

This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Primary Open-Angle Glaucoma
• Intervention / Treatment: Drug: Bimatoprost

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Vold Vision
  • California
    • Artesia, California, United States, 90701
      • Sall Medical Research Center
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Mundorf Eye Center
    • High Point, North Carolina, United States, 27262
      • Cornerstone Health Care; Cornerstone Eye Care
  • Tennessee
    • Maryville, Tennessee, United States, 37803
      • University Eye Specialists
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care
  • Texas
    • San Antonio, Texas, United States, 78229
      • R&R Eye Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Completed FSV5-004 study.
2. Written informed consent prior to any study procedure.
3. Willingness to comply with the visit schedule.

Key Exclusion Criteria:

1. Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
2. Subjects who will require contact lens use during the study period.
3. Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 13 mg Bimatoprost Ocular Insert; 13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.	Drug: Bimatoprost; Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.; Other Names: "Lumigan" is the branded name of bimatoprost in eye drop form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity	An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.	Baseline (Day 0, enrollment in this study) to end of study (Week 38)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Intraocular Pressure (IOP)	IOP is a measurement of the fluid pressure inside the eye. IOP measurements were taken at 8 am (Time (T)=0 hour) at Weeks 4, 8, 12, 24 and 38. Diurnal IOP measurements were also taken at 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 12, 24 and 38. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the Randomization visit (Day 0) of study FSV5-004.	Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
Percentage of Participants by Subject-Reported Comfort Assessment Categories	The participant assessed their overall comfort with ocular inserts using the following rating choices: Not aware of inserts, very comfortable; Aware of inserts, and comfortable; Tolerable, but mild discomfort; Moderate discomfort or Severe discomfort. The percentage of participants in each rating category is reported.	Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
Bimatoprost Ocular Insert Retention Duration	Insert duration was defined as the total duration (in days) that any ocular insert remained in place for each subject, measured from the date of Insert removal minus date of Insert placement + 1.	Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
Percentage of Participants Who Received Rescue Treatment	Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP.	Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
Change From Baseline in Endothelial Cell Count	Density (number of cells/mm^2) of corneal endothelial cells was determined at four sites using specular microscopy of the central corneal endothelium at Baseline and at Week 38.	Baseline (Day 0, enrollment in this study) to end of study (Week 38)

Collaborators and Investigators

• Sponsor: ForSight Vision5, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2015
• Primary Completion (Actual): August 11, 2016
• Study Completion (Actual): August 11, 2016

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: FSV5-005 OLE 2