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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537015
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : February 26, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
ForSight Vision5, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Primary Open-Angle Glaucoma Ocular Hypertension Drug: Bimatoprost Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 10, 2015
Actual Primary Completion Date : August 11, 2016
Actual Study Completion Date : August 11, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

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 Name: "Lumigan" is the branded name of bimatoprost in eye drop form




Primary Outcome Measures :
  1. Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity [ Time Frame: Baseline (Day 0, enrollment in this study) to end of study (Week 38) ]
    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.


Other Outcome Measures:
  1. Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38 ]
    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.

  2. Percentage of Participants by Subject-Reported Comfort Assessment Categories [ Time Frame: Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38 ]
    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.

  3. Bimatoprost Ocular Insert Retention Duration [ Time Frame: Baseline (Day 0, enrollment in this study) to the end of study (Week 38) ]
    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.

  4. Percentage of Participants Who Received Rescue Treatment [ Time Frame: Baseline (Day 0, enrollment in this study) to the end of study (Week 38) ]
    Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP.

  5. Change From Baseline in Endothelial Cell Count [ Time Frame: Baseline (Day 0, enrollment in this study) to end of study (Week 38) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537015


Locations
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United States, Arkansas
Vold Vision
Fayetteville, Arkansas, United States, 72704
United States, California
Sall Medical Research Center
Artesia, California, United States, 90701
Eye Research Foundation
Newport Beach, California, United States, 92663
United States, Georgia
Clayton Eye Center
Morrow, Georgia, United States, 30260
United States, North Carolina
Mundorf Eye Center
Charlotte, North Carolina, United States, 28204
Cornerstone Health Care; Cornerstone Eye Care
High Point, North Carolina, United States, 27262
United States, Tennessee
University Eye Specialists
Maryville, Tennessee, United States, 37803
Total Eye Care
Memphis, Tennessee, United States, 38119
United States, Texas
R&R Eye Research, LLC
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
ForSight Vision5, Inc.
Investigators
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Study Director: Michelle Chen, PhD Allergan
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Responsible Party: ForSight Vision5, Inc.
ClinicalTrials.gov Identifier: NCT02537015    
Other Study ID Numbers: FSV5-005 OLE 2
First Posted: September 1, 2015    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: April 2, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents