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This is a multiple cohort study that will evaluate the safety and efficacy of ENV515 travoprost XR in patients with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | ENV515-1 and ENV515-3 implants in Study Eye for 28 days |
|
| Cohort 2 | Experimental | Two ENV515-3 implants in Study Eye for 12 months with optional 6 month and 3 month extensions (total of 21 months) |
|
| Cohort 3 | Experimental | One or two ENV515-3-2 implants in Study Eye with optional 6 months and additional 6 month extension (total of 24 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENV515-3 Travoprost XR | Drug |
| ||
| ENV515-1 Travoprost XR |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1) | Average intraocular pressure (IOP) diurnal measurement is calculated by taking the average of the intraocular pressure measurements at 8AM, 10AM and 4PM. The protocol was later amended (Amendment 09) to a safety only study so the diurnal measurements were no longer collected for Cohorts 2 and 3; only the 8AM IOP was collected as a safety assessment only. | Baseline and Day 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler | Arizona | 85225 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - Group 1 | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days |
| FG001 | Cohort 1 - Group 2 | 3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2018 | Jun 28, 2019 |
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| Drug |
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| ENV515-3-2 Travoprost XR | Drug |
|
| Garden Grove |
| California |
| 92843 |
| United States |
| Inglewood | California | 90301 | United States |
| Redding | California | 96002 | United States |
| Morrow | Georgia | 30260 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Chesterfield | Missouri | 63017 | United States |
| Kansas City | Missouri | 64133 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Portland | Oregon | 97210 | United States |
| Sioux Falls | South Dakota | 57108 | United States |
| Austin | Texas | 78731 | United States |
| Houston | Texas | 77025 | United States |
| San Antonio | Texas | 78229 | United States |
| FG002 | Cohort 1 - Group 3 | 1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days |
| FG003 | Cohort 1 - Group 4 | 2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days |
| FG004 | Cohort 2 | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months |
| FG005 | Cohort 3 - Group 1 | 1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months |
| FG006 | Cohort 3 - Group 2 | 2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - Group 1 | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days |
| BG001 | Cohort 1 - Group 2 | 3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days |
| BG002 | Cohort 1 - Group 3 | 1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days |
| BG003 | Cohort 1 - Group 4 | 2 ENV515-3 implants (85.0 μg travoprost) in Study Eye for 28 days |
| BG004 | Cohort 2 | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months |
| BG005 | Cohort 3 - Group 1 | 1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months |
| BG006 | Cohort 3 - Group 2 | 2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3. | Mean | Standard Deviation | Years |
| |||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||
| Intraocular Pressure (mm Hg) | All IOPs were measured with a Goldmann applanation tonometer. | Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3. | Mean | Standard Deviation | mm Hg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1) | Average intraocular pressure (IOP) diurnal measurement is calculated by taking the average of the intraocular pressure measurements at 8AM, 10AM and 4PM. The protocol was later amended (Amendment 09) to a safety only study so the diurnal measurements were no longer collected for Cohorts 2 and 3; only the 8AM IOP was collected as a safety assessment only. | Safety Population | Posted | Mean | Standard Deviation | mm Hg | Baseline and Day 25 |
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Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 - Group 1 | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days | 0 | 7 | 0 | 7 | 4 | 7 |
| EG001 | Cohort 1 - Group 2 | 3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days | 0 | 10 | 1 | 10 | 7 | 10 |
| EG002 | Cohort 2 - Group 3 | 1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days | 0 | 2 | 0 | 2 | 2 | 2 |
| EG003 | Cohort 1 - Group 4 | 2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days | 0 | 2 | 0 | 2 | 2 | 2 |
| EG004 | Cohort 2 | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months | 0 | 5 | 0 | 5 | 5 | 5 |
| EG005 | Cohort 3 - Group 1 | 1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months | 0 | 6 | 0 | 6 | 6 | 6 |
| EG006 | Cohort 3 - Group 2 | 2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months | 0 | 9 | 4 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal edema | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Corneal endothelial cell loss | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Paget's disease of the right nipple | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Cystocele | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
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| Meniere's disease | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
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| Anterior chamber cell | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Anterior chamber flare | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Anterior chamber inflammation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Chalazion | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Conjunctival oedema | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Corneal edema | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Corneal endothelial cell loss | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Corneal epithelial microcysts | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Corneal opacity | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Corneal thickening | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Eye allergy | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Eye inflammation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Eye pruritis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Eyelid oedema | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Eyelid ptosis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Iris adhesions | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Iris disorder | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Iritis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Keratitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Macular degeneration | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Narrow anterior chamber angle | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Optic disc haemorrhage | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Photopsia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Posterior capsule opacification | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Recession of chamber angle of eye | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Trichiasis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Large intestinal polyp | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Instillation site pain | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Upper respiratory track infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Eosinophil count increased | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Visual field defect | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
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| Bladder prolapse | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Hyperemia | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Blackwell, Consultant, Regulatory Affairs & Quality Assurance | Envisia Therapeutics, Inc. | 919-219-6448 | kristin.blackwell@envtx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 23, 2015 | Jun 28, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Cohorts 2 and 3 |
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| Cohorts 2 and 3 |
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