Back to resultsDose-Ranging Study of the Bimatoprost Ocular Insert
Primary Purpose
Primary Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost
Timolol 0.5%
Placebo Ocular Insert
Placebo Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open-Angle Glaucoma
Eligibility Criteria
Key Inclusion Criteria:
- Written informed consent
- At least 18 years of age
- Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
- Best corrected-distance visual acuity score equivalent to 20/80 or better
- Stable visual field
- Central corneal thickness between 490 - 620 micrometers
Inclusion Criteria at the Randomization Visit:
("T" is defined as time and "hr" is defined as hour[s])
- IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.
- Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.
- IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.
Key Exclusion Criteria:
- Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
- A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of beta-blocker drops
- Cup-to-disc ratio of greater than 0.8
- Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than Grade 2 based on gonioscopy
- Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
- Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
- Past history of any incisional surgery for glaucoma at any time
- Past history of corneal refractive surgery
- Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
- Current participation in an investigational drug or device study or participation in such a study within 30 days of Screening
- Inability to adequately evaluate the retina
- Participants who will require contact lens use during the study period.
- Participants who currently have punctal occlusion
- Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
Sites / Locations
- Vold Vision
- Sall Medical Research Center
- Eye Research Foundation
- Clayton Eye Center
- Mundorf Eye Center
- Cornerstone Health Care
- Apex Eye
- University of Eye Specialists
- Total Eye Care
- R&R Eye Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
13 mg Bimatoprost Ocular Insert
2.2 mg Bimatoprost Ocular Insert
Timolol 0.5%
Arm Description
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye (OU) for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops to each eye twice a day (BID) for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 2.2 mg Bimatoprost Ocular Insert in each eye for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops in each eye twice a day for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 0.5% timolol ophthalmic solution in each eye for 6 weeks. Note: participants simultaneously wore placebo ocular inserts for 12 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Intraocular Pressure (IOP) at Week 8
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 8. 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.
Change From Baseline in IOP at Week 12
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. 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.
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12
The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination.
Change From Baseline in Automated Visual Field at Week 12
Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement.
Dilated Fundus Exam: Cup-to-Disc-Ratio
The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma.
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported.
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
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. Th 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.
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
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.
Secondary Outcome Measures
Change From Baseline in IOP at Week 2
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. 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.
Change From Baseline in IOP at Week 6
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. 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.
Change From Baseline in IOP in Period C
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 14, 18 and 24. 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02358369
Brief Title
Dose-Ranging Study of the Bimatoprost Ocular Insert
Official Title
A Phase 2 Prospective, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety and Dose-response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) With and Without Concomitant Artificial Tears Compared to a Placebo Ocular Insert With and Without Concomitant Timolol (0.5%) Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 19, 2015 (Actual)
Primary Completion Date
August 31, 2015 (Actual)
Study Completion Date
October 7, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ForSight Vision5, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-Angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
13 mg Bimatoprost Ocular Insert
Arm Type
Experimental
Arm Description
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye (OU) for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops to each eye twice a day (BID) for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Arm Title
2.2 mg Bimatoprost Ocular Insert
Arm Type
Experimental
Arm Description
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 2.2 mg Bimatoprost Ocular Insert in each eye for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops in each eye twice a day for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Arm Title
Timolol 0.5%
Arm Type
Active Comparator
Arm Description
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 0.5% timolol ophthalmic solution in each eye for 6 weeks. Note: participants simultaneously wore placebo ocular inserts for 12 weeks.
After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost
Intervention Description
Bimatoprost sustained release Ocular Insert
Intervention Type
Drug
Intervention Name(s)
Timolol 0.5%
Intervention Description
BID drops OU, 0.5% ophthalmic solution
Intervention Type
Device
Intervention Name(s)
Placebo Ocular Insert
Intervention Description
Placebo ocular insert OU.
Intervention Type
Drug
Intervention Name(s)
Placebo Eye Drops
Intervention Description
Placebo eye drops BID OU.
Primary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure (IOP) at Week 8
Description
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 8. 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.
Time Frame
Baseline (Day 0) to Week 8
Title
Change From Baseline in IOP at Week 12
Description
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. 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.
Time Frame
Baseline (Day 0) to Week 12
Title
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame
Baseline (Day 0) to Week 8
Title
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame
Baseline (Day 0) to Week 12
Title
Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12
Description
The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline in Automated Visual Field at Week 12
Description
Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement.
Time Frame
Baseline (Day 0) to Week 12
Title
Dilated Fundus Exam: Cup-to-Disc-Ratio
Description
The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma.
Time Frame
Week 12
Title
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Description
Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported.
Time Frame
Week 12
Title
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
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. Th 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) to Week 12
Title
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
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
Week 12 to Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in IOP at Week 2
Description
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. 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.
Time Frame
Baseline (Day 0) to Week 2
Title
Change From Baseline in IOP at Week 6
Description
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. 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.
Time Frame
Baseline (Day 0) to Week 6
Title
Change From Baseline in IOP in Period C
Description
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 14, 18 and 24. 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.
Time Frame
Baseline (Day 0) to Weeks 14, 18 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Written informed consent
At least 18 years of age
Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
Best corrected-distance visual acuity score equivalent to 20/80 or better
Stable visual field
Central corneal thickness between 490 - 620 micrometers
Inclusion Criteria at the Randomization Visit:
("T" is defined as time and "hr" is defined as hour[s])
IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.
Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.
IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.
Key Exclusion Criteria:
Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of beta-blocker drops
Cup-to-disc ratio of greater than 0.8
Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than Grade 2 based on gonioscopy
Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
Past history of any incisional surgery for glaucoma at any time
Past history of corneal refractive surgery
Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
Current participation in an investigational drug or device study or participation in such a study within 30 days of Screening
Inability to adequately evaluate the retina
Participants who will require contact lens use during the study period.
Participants who currently have punctal occlusion
Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Chen, PhD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Vold Vision
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Facility Name
Sall Medical Research Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Clayton Eye Center
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Mundorf Eye Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Cornerstone Health Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Apex Eye
City
Madeira
State/Province
Ohio
ZIP/Postal Code
45243
Country
United States
Facility Name
University of Eye Specialists
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
R&R Eye Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose-Ranging Study of the Bimatoprost Ocular Insert
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