- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02742649
A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension
February 7, 2019 updated by: ForSight Vision5, Inc.
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Panama City, Panama
- Clinica de Ojos Orillac - Calvo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fixed Combination (FC) Ocular Insert
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.
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Continuous elution from the ocular insert.
Other Names:
One segment of placebo (no drug product)
0.5% timolol drops twice daily.
|
Experimental: Bimatoprost Ocular Insert
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.
|
One segment of placebo (no drug product)
0.5% timolol drops twice daily.
Continuous elution from the ocular insert.
This is an active control arm.
Other Names:
|
Experimental: Timolol Ocular Insert
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.
|
One segment of placebo (no drug product)
0.5% timolol drops twice daily.
Continuous elution from the ocular insert.
This is an active control arm.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular Pressure (IOP) on Day 8
Time Frame: 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.
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Day 8
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IOP on Day 16
Time Frame: 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.
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Day 16
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IOP on Day 28
Time Frame: 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.
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Day 28
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IOP on Day 49
Time Frame: Day 49
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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.
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Day 49
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IOP on Day 70
Time Frame: 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.
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Day 70
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Ocular and Non-Ocular Adverse Events
Time Frame: From Randomization (Day 0) to Day 70
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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.
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From Randomization (Day 0) to Day 70
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IOP During Open Label Period
Time Frame: Day 98, Day 112
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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.
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Day 98, Day 112
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2016
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
April 6, 2016
First Submitted That Met QC Criteria
April 14, 2016
First Posted (Estimate)
April 19, 2016
Study Record Updates
Last Update Posted (Actual)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 7, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Timolol
- Bimatoprost
Other Study ID Numbers
- FSV5-FC-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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