Back to resultsA Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 1
Locations
Panama
Study Type
Interventional
Intervention
Fixed Combination
Bimatoprost
Timolol
Placebo Segment
Timolol 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for 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:
- IOP for each eye is ≥ 23 mmHg at T=0hr, ≥ 20 mmHg at T=4hr and T=8hr.
- Inter-eye IOP difference of ≤ 5.0 mmHg at T=0hr, T=4hr and T=8hr.
- IOP for each eye is ≤ 30 mmHg at T=0hr, T=4hr and T=8hr.
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 a topical beta-blocker
- Use of any agents known to have a substantial effect on IOP during planned study period (e.g. beta-blockers)
- 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 7 days of Screening
- Inability to adequately evaluate the retina
- Subjects who will require contact lens use during the study period.
- Subjects who currently have punctal occlusion
- Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
Sites / Locations
- Clinica de Ojos Orillac - Calvo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Fixed Combination (FC) Ocular Insert
Bimatoprost Ocular Insert
Timolol Ocular Insert
Arm Description
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one segment of timolol maleate combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of timolol and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP) on Day 8
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 16
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 28
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 49
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 70
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Secondary Outcome Measures
Number of Participants With Ocular and Non-Ocular Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Reported here is the number of participants with adverse events related to the eye as well as number of participants with all other adverse events.
IOP During Open Label Period
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour) at the start (Day 98) and end (Day 112) of the Open Label Period during which participants were treated with timolol 0.5% ophthalmic solution twice daily. The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02742649
Brief Title
A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension
Official Title
A Phase 1B, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety of a Fixed Combination Bimatoprost/Timolol Ocular Insert Compared to Its Individual Components With Crossover to Timolol 0.5% in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 30, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (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 purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed Combination (FC) Ocular Insert
Arm Type
Experimental
Arm Description
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one segment of timolol maleate combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
Arm Title
Bimatoprost Ocular Insert
Arm Type
Experimental
Arm Description
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
Arm Title
Timolol Ocular Insert
Arm Type
Experimental
Arm Description
Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of timolol and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
Intervention Type
Drug
Intervention Name(s)
Fixed Combination
Other Intervention Name(s)
Bimatoprost-Timolol combination
Intervention Description
Continuous elution from the ocular insert.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost
Other Intervention Name(s)
Bimatoprost component only
Intervention Description
Continuous elution from the ocular insert. This is an active control arm.
Intervention Type
Drug
Intervention Name(s)
Timolol
Other Intervention Name(s)
Timolol component only
Intervention Description
Continuous elution from the ocular insert. This is an active control arm.
Intervention Type
Device
Intervention Name(s)
Placebo Segment
Intervention Description
One segment of placebo (no drug product)
Intervention Type
Drug
Intervention Name(s)
Timolol 0.5%
Intervention Description
0.5% timolol drops twice daily.
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) on Day 8
Description
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Time Frame
Day 8
Title
IOP on Day 16
Description
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Time Frame
Day 16
Title
IOP on Day 28
Description
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Time Frame
Day 28
Title
IOP on Day 49
Description
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Time Frame
Day 49
Title
IOP on Day 70
Description
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Time Frame
Day 70
Secondary Outcome Measure Information:
Title
Number of Participants With Ocular and Non-Ocular Adverse Events
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Reported here is the number of participants with adverse events related to the eye as well as number of participants with all other adverse events.
Time Frame
From Randomization (Day 0) to Day 70
Title
IOP During Open Label Period
Description
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour) at the start (Day 98) and end (Day 112) of the Open Label Period during which participants were treated with timolol 0.5% ophthalmic solution twice daily. The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Time Frame
Day 98, Day 112
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:
IOP for each eye is ≥ 23 mmHg at T=0hr, ≥ 20 mmHg at T=4hr and T=8hr.
Inter-eye IOP difference of ≤ 5.0 mmHg at T=0hr, T=4hr and T=8hr.
IOP for each eye is ≤ 30 mmHg at T=0hr, T=4hr and T=8hr.
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 a topical beta-blocker
Use of any agents known to have a substantial effect on IOP during planned study period (e.g. beta-blockers)
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 7 days of Screening
Inability to adequately evaluate the retina
Subjects who will require contact lens use during the study period.
Subjects 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
Clinica de Ojos Orillac - Calvo
City
Panama City
Country
Panama
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension
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