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

Ocular Hypertension Clinical Trial

— OLE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537015
• Other study ID #: FSV5-005 OLE 2
• Status: Completed
• Phase: Phase 2
• Start date: August 10, 2015
• Est. completion date: August 11, 2016

Study information

• Verified date: March 2019
• Source: ForSight Vision5, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 11, 2016
• Est. primary completion date: August 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-Angle Glaucoma

Intervention

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.

Locations

Country	Name	City	State
United States	Sall Medical Research Center	Artesia	California
United States	Mundorf Eye Center	Charlotte	North Carolina
United States	Vold Vision	Fayetteville	Arkansas
United States	Cornerstone Health Care; Cornerstone Eye Care	High Point	North Carolina
United States	University Eye Specialists	Maryville	Tennessee
United States	Total Eye Care	Memphis	Tennessee
United States	Clayton Eye Center	Morrow	Georgia
United States	Eye Research Foundation	Newport Beach	California
United States	R&R Eye Research, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ForSight Vision5, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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)
Other	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)
Other	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)
Primary	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)