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

Sponsor
ForSight Vision5, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02537015
Collaborator
(none)
81
9
1
12.1
9
0.7

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Aug 10, 2015
Actual Primary Completion Date :
Aug 11, 2016
Actual Study Completion Date :
Aug 11, 2016

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity [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) [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vold Vision Fayetteville Arkansas United States 72704
    2 Sall Medical Research Center Artesia California United States 90701
    3 Eye Research Foundation Newport Beach California United States 92663
    4 Clayton Eye Center Morrow Georgia United States 30260
    5 Mundorf Eye Center Charlotte North Carolina United States 28204
    6 Cornerstone Health Care; Cornerstone Eye Care High Point North Carolina United States 27262
    7 University Eye Specialists Maryville Tennessee United States 37803
    8 Total Eye Care Memphis Tennessee United States 38119
    9 R&R Eye Research, LLC San Antonio Texas United States 78229

    Sponsors and Collaborators

    • ForSight Vision5, Inc.

    Investigators

    • Study Director: Michelle Chen, PhD, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ForSight Vision5, Inc.
    ClinicalTrials.gov Identifier:
    NCT02537015
    Other Study ID Numbers:
    • FSV5-005 OLE 2
    First Posted:
    Sep 1, 2015
    Last Update Posted:
    Apr 2, 2019
    Last Verified:
    Mar 1, 2019

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Participants who completed the Phase 2 study FSV5-004 [NCT02358369] were eligible to enroll in this open-label extension study.
    Arm/Group Title 13 mg Bimatoprost Ocular Insert
    Arm/Group Description 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.
    Period Title: Overall Study
    STARTED 81
    COMPLETED 75
    NOT COMPLETED 6

    Baseline Characteristics

    Arm/Group Title 13 mg Bimatoprost Ocular Insert
    Arm/Group Description 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.
    Overall Participants 81
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    64.8
    (9.89)
    Sex: Female, Male (Count of Participants)
    Female
    52
    64.2%
    Male
    29
    35.8%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    Safety Population included all enrolled participants who had at least one 13 mg Bimatoprost Ocular Insert placed.
    Arm/Group Title 13 mg Bimatoprost Ocular Insert
    Arm/Group Description 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.
    Measure Participants 81
    Ocular, Mild
    25.9
    32%
    Ocular, Moderate
    11.1
    13.7%
    Ocular, Severe
    0
    0%
    Non-Ocular, Mild
    6.2
    7.7%
    Non-Ocular, Moderate
    8.6
    10.6%
    Non-Ocular, Severe
    4.9
    6%
    2. Other Pre-specified Outcome
    Title Change From Baseline in Intraocular Pressure (IOP)
    Description 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.
    Time Frame Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    3. Other Pre-specified Outcome
    Title Percentage of Participants by Subject-Reported Comfort Assessment Categories
    Description 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.
    Time Frame Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Other Pre-specified Outcome
    Title Bimatoprost Ocular Insert Retention Duration
    Description 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.
    Time Frame Baseline (Day 0, enrollment in this study) to the end of study (Week 38)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    5. Other Pre-specified Outcome
    Title Percentage of Participants Who Received Rescue Treatment
    Description Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP.
    Time Frame Baseline (Day 0, enrollment in this study) to the end of study (Week 38)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    6. Other Pre-specified Outcome
    Title Change From Baseline in Endothelial Cell Count
    Description 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.
    Time Frame Baseline (Day 0, enrollment in this study) to end of study (Week 38)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
    Adverse Event Reporting Description
    Arm/Group Title 13 mg Bimatoprost Ocular Insert
    Arm/Group Description 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.
    All Cause Mortality
    13 mg Bimatoprost Ocular Insert
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    13 mg Bimatoprost Ocular Insert
    Affected / at Risk (%) # Events
    Total 7/81 (8.6%)
    Cardiac disorders
    Atrial fibrillation 1/81 (1.2%)
    Hepatobiliary disorders
    Cholelithiasis 1/81 (1.2%)
    Injury, poisoning and procedural complications
    Hip fracture 1/81 (1.2%)
    Upper limb fracture 1/81 (1.2%)
    Metabolism and nutrition disorders
    Fluid overload 1/81 (1.2%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 1/81 (1.2%)
    Vascular disorders
    Hypertension 1/81 (1.2%)
    Other (Not Including Serious) Adverse Events
    13 mg Bimatoprost Ocular Insert
    Affected / at Risk (%) # Events
    Total 20/81 (24.7%)
    Eye disorders
    Punctate keratitis 10/81 (12.3%)
    Eye discharge 9/81 (11.1%)
    Ocular discomfort 5/81 (6.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    No presentation or publication of Institution's data relating to the Trial may occur until after the Trial has been completed at all sites. If Investigator desires to present or publish, investigator must submit any and all manuscripts, posters, abstracts, or other intended publications (hereinafter collectively referred to as "manuscripts") to Sponsor at least sixty (60) days prior to the actual submission of such manuscript(s) for publication.

    Results Point of Contact

    Name/Title Therapeutic Area Head,
    Organization Allergan, Inc
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    ForSight Vision5, Inc.
    ClinicalTrials.gov Identifier:
    NCT02537015
    Other Study ID Numbers:
    • FSV5-005 OLE 2
    First Posted:
    Sep 1, 2015
    Last Update Posted:
    Apr 2, 2019
    Last Verified:
    Mar 1, 2019