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This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic Solution 4.0% administered once (AM) or twice (AM & PM) daily when used as an adjunctive therapy to latanoprost ophthalmic solution 0.005% once daily (PM) in subjects with elevated IOP due to OAG or OHT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKB-9778 4% QD + Latanoprost | Experimental | • AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days |
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| AKB-9778 4% BID + Latanoprost | Experimental | • AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days |
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| Placebo Twice Daily + Latanoprost | Placebo Comparator | • Placebo for AKB-9778 4% ophthalmic solution twice daily (AM & PM) plus latanoprost daily (PM) for 28 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost ophthalmic solution | Drug | Latanoprost opthalmic solution to be dosed once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure at Day 28 (Study Eye) | Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye) | Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population | Baseline to Day 14 |
| Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Medical Research Institute | Inglewood | California | 90301 | United States | ||
| North Valley Eye Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | AKB-9778 4% QD + Latanoprost | • AKB-9778 4% QD (AM) and placebo for AKB-9778 ophthalmic solution QD (PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily AKB-9778: AKB-9778 4% ophthalmic solution |
| FG001 | AKB-9778 4% BID + Latanoprost |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2021 |
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| AKB-9778 4% | Drug | Razuprotafib opthalmic solution |
|
| Placebo | Drug | placebo for razuprotafib opthalmic solution |
|
Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population |
| Baseline to Day 14 and Baseline to Day 28 |
| Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population | Baseline to Day 14 and Baseline to Day 28 |
| Mean Observed IOP at Each Time Point on Days 14 and 28 | Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population | Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 |
| Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population | Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 |
| Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population | Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 |
| Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 | Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population | Baseline to Day 14 and Baseline to Day 28 |
| Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population | Baseline to Day 28 |
| Mission Hills |
| California |
| 91345 |
| United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| North Bay Eye Associates | Petaluma | California | 94954 | United States |
| Shettle Eye Research | Largo | Florida | 33773 | United States |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | United States |
| Coastal Research Associates | Roswell | Georgia | 30076 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Heart of America Eye Care, P.A. | Shawnee Mission | Kansas | 66204 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| North Valley Eye Medical Group | Rochester | New York | 14618 | United States |
| Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA) | Charlotte | North Carolina | 28210 | United States |
| James D. Branch, MD Ophthalmology | Winston-Salem | North Carolina | 27101 | United States |
| Apex Eye | Cincinnati | Ohio | 45242 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Mark J. Weiss, MD, Inc. | Tulsa | Oklahoma | 74104 | United States |
| Scott & Christie and Assoc | Cranberry Township | Pennsylvania | 16066 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| Advancing Vision Research | Nashville | Tennessee | 37205 | United States |
| Texan Eye / Keystone Research | Austin | Texas | 78731 | United States |
• AKB-9778 4% BID (AM & PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily AKB-9778: AKB-9778 4% ophthalmic solution |
| FG002 | Placebo BID + Latanoprost | • Placebo for AKB-9778 4% ophthalmic solution BID (AM & PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily Placebo: placebo for AKB-9778 4% ophthalmic solution |
| COMPLETED |
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| NOT COMPLETED |
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Each Baseline participant contributed one study eye and one fellow eye
| ID | Title | Description |
|---|---|---|
| BG000 | AKB-9778 4% QD + Latanoprost | • AKB-9778 4%(AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: razuprotafib opthalmic solution |
| BG001 | AKB-9778 4% BID + Latanoprost | • AKB-9778 4% BID (AM & PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: razuprotafib opthalmic solution |
| BG002 | Placebo Twice Daily + Latanoprost | • Placebo for AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for razuprotafib opthalmic solution |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Diagnosis | Study Eye must meet ALL ophthalmic inclusion and no exclusion criteria; Fellow Eye is the non-Study Eye. Fellow Eye may meet ophthalmic inclusion and exclusion criteria, but is not required. | Count of Units | Eyes | Eyes |
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| Randomization Intraocular Pressure (Study Eye) | Only the Study Eye of the 65 participants was measured in this table | Count of Participants | Participants | Participants |
| ||||||||||||||
| Study Eye Screening Corneal Thickness (micrometers) | Only the Study Eye of the 65 participants was measured in this table | Mean | Standard Deviation | micrometer | Participants |
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| Study Eye Screening Intraocular Pressure (mmHg) | Only the Study Eye of the 65 participants was measured in this table | Mean | Standard Deviation | mmHg | Participants |
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| Study Eye Baseline Diurnal Mean Intraocular Pressure (mmHg) | Only the Study Eye of the 65 participants was measured in this table | Mean | Standard Deviation | mmHg | Participants |
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| 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 | Change From Baseline in Intraocular Pressure at Day 28 (Study Eye) | Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population | The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline to Day 28 |
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| Secondary | Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye) | Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population | The Intent-to-Treat population includes all randomized subjects who received at least one dose of study medication. the primary population for efficacy analyses and was used to summarize all efficacy variables and summarizes subjects as randomized. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline to Day 14 |
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| Secondary | Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population | The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline to Day 14 and Baseline to Day 28 | eyes | eyes |
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| Secondary | Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population | The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized. | Posted | Mean | Standard Deviation | mmHg | Baseline to Day 14 and Baseline to Day 28 | eyes | eyes |
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| Secondary | Mean Observed IOP at Each Time Point on Days 14 and 28 | Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population | The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized. | Posted | Mean | Standard Deviation | mmHg | Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 |
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| Secondary | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population | The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized. | Posted | Mean | Standard Deviation | mmHg | Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 |
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| Secondary | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population | The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized. | Posted | Least Squares Mean | Standard Error | percent change | Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 |
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| Secondary | Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 | Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population | The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized. | Posted | Mean | Standard Deviation | percent change | Baseline to Day 14 and Baseline to Day 28 |
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| Secondary | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population | The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized. | Posted | Count of Participants | Participants | Baseline to Day 28 |
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Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks.
The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
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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 | AKB-9778 4% QD + Latanoprost | • AKB-9778 4% QD (AM) and placebo for AKB-9778 ophthalmic solution QD (PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily AKB-9778: AKB-9778 4% ophthalmic solution | 0 | 65 | 0 | 65 | 30 | 65 |
| EG001 | AKB-9778 4% BID + Latanoprost | • AKB-9778 4% BID (AM & PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily AKB-9778: AKB-9778 4% ophthalmic solution | 0 | 65 | 0 | 65 | 43 | 65 |
| EG002 | Placebo BID + Latanoprost | • Placebo for AKB-9778 4% ophthalmic solution BID (AM & PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily Placebo: placebo for AKB-9778 4% ophthalmic solution | 0 | 64 | 0 | 64 | 19 | 64 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Conjunctivitis allergic | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Dry Eye | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Eye Pruritus | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Eyelid margin crusting | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Iritis | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Photophobia | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Punctate keratitis | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Retinal artery emoblism | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Vision blurred | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Visual impairment | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Vitreous disorder | Eye disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Instillation site foreign body sensation | General disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Instillation site pain | General disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Instillation site pruritis | General disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Sensation of foreign body | General disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Migraine with aura | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment | ocular TEAE |
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| Glossodynia | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment | non-ocular TEAE |
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| Nausea | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment | non-ocular TEAE |
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| Urinary tract infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment | non-ocular TEAE |
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| Dysgeusia | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment | non-ocular TEAE |
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| Headache | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment | non-ocular TEAE |
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Product acquired from Aerpio with limited transfer of documents. Site CTAs not provided.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Bauer | EyePoint Pharmaceuticals, Inc | 8573410747 | dbauer@eyepointpharma.com |
| Sep 20, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Ocular hypertension - Study Eye |
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| Open-angle glaucoma - Fellow Eye |
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| Ocular hypertension - Fellow Eye |
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| Diurnal Mean >=26 mmHg |
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| Mean Difference (Final Values) |
| -0.92 |
| Standard Error of the Mean |
| 0.365 |
| 2-Sided |
| 95 |
| -1.64 |
| -0.20 |
| Superiority |
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• Placebo for AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily
Placebo: placebo for Razuprotafib opthalmic solution
|
|
|
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• Placebo for AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily
Placebo: placebo for Razuprotafib opthalmic solution
|
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