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Phase 3 study to evaluate the extended safety of RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RVL-1201 Ophthalmic Solution, 0.1% | Experimental | RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% |
|
| Vehicle ophthalmic solution | Placebo Comparator | Vehicle placebo ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RVL-1201 | Drug | RVL-1201 ophthalmic solution, 0.1% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84 | Intraocular pressure will be measured in mmHg utilizing a tonometer and using the standard of care. If possible, the same calibrated instrument should be used for a given subject throughout the study. | Screening/Day 1 to Day 84 |
| Mean Change From Baseline in Pupil Diameter (PD) at Day 84 | Pupil diameter will be measured in millimeters (either horizontally or vertically if top of pupil is not visible in photograph) from the external photograph. | Screening/Day 1 to Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnet, Dulany Perkins | Phoenix | Arizona | 85016 | United States | ||
| Orange County Ophthalmology Medical Group |
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Planned sample size approximately 225 subjects, 150 subjects in the RVL-1201 group and 75 subjects in the Vehicle group, to be enrolled at approximately 30 clinical sites in the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | RVL-1201 Ophthalmic Solution, 0.1% | RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days |
| FG001 | Vehicle Ophthalmic Solution | Vehicle placebo ophthalmic solution One drop each eye QD for 84 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 | Oct 24, 2018 | Aug 4, 2020 |
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| Vehicle ophthalmic solution |
| Other |
Vehicle placebo ophthalmic solution |
|
| Garden Grove |
| California |
| 92843 |
| United States |
| North Valley Eye Medical | Mission Hills | California | 91345 | United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Pendelton Eye Center | Oceanside | California | 92056 | United States |
| North Bay Eye Associates | Petaluma | California | 94954 | United States |
| Michael K. Tran, MD Inc. | Westminster | California | 92683 | United States |
| Danbury Eye Physicians and Surgeons | Danbury | Connecticut | 06810 | United States |
| Hernando Eye Institute | Brooksville | Florida | 34615 | United States |
| Shettle Eye Research | Largo | Florida | 33773 | United States |
| West Coast Eye Institute | Lecanto | Florida | 34461 | United States |
| Sabal Eye Care | Longwood | Florida | 32779 | United States |
| Maitland Vision Center | Maitland | Florida | 32751 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Coastal Research Associates | Roswell | Georgia | 30076 | United States |
| Kennar Eye Care | Pittsburg | Kansas | 66762 | United States |
| Heart of America Eye Care | Shawnee Mission | Kansas | 66204 | United States |
| Seidenberg Protzko Eye Associates | Havre de Grace | Maryland | 21078 | United States |
| Mississippi Eye Associates | Ocean Springs | Mississippi | 39564 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| Comprehensive Eye Care | Washington | Missouri | 63090 | United States |
| Rochester Ophthalmological Group | Rochester | New York | 14618 | United States |
| South Shore Eye Care | Wantagh | New York | 11793 | United States |
| CEENTA | Charlotte | North Carolina | 28210 | United States |
| Cornerstone Eye Care | High Point | North Carolina | 27262 | United States |
| Drs. Quinn, Foster & Associates | Athens | Ohio | 45701 | United States |
| Apex Eye | Cincinnati | Ohio | 45243 | United States |
| Apex Eye | Cincinnati | Ohio | 45247 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Nashville Vision Associates | Nashville | Tennessee | 37205 | United States |
| Round Rock Eye Consultants | Austin | Texas | 78681 | United States |
| Texan Eye / Keystone Research, Ltd. | Austin | Texas | 78731 | United States |
| Lake Travis Eye and Laser Center | Lakeway | Texas | 78734-5304 | United States |
| R & R Research | San Antonio | Texas | 78229 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | RVL-1201 Ophthalmic Solution, 0.1% | RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days |
| BG001 | Vehicle Ophthalmic Solution | Vehicle placebo ophthalmic solution One drop each eye QD for 84 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | 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 | Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84 | Intraocular pressure will be measured in mmHg utilizing a tonometer and using the standard of care. If possible, the same calibrated instrument should be used for a given subject throughout the study. | The safety population includes all subjects who receive at least one dose of double-masked study treatment and have at least one post-dose visit. | Posted | Mean | Standard Deviation | mmHg | Screening/Day 1 to Day 84 |
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| Primary | Mean Change From Baseline in Pupil Diameter (PD) at Day 84 | Pupil diameter will be measured in millimeters (either horizontally or vertically if top of pupil is not visible in photograph) from the external photograph. | The safety population includes all subjects who receive at least one dose of double-masked study treatment and have at least one post-dose visit. | Posted | Mean | Standard Deviation | Millimeters (mm) | Screening/Day 1 to Day 84 |
|
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Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study).
AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).
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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 | RVL-1201 Ophthalmic Solution, 0.1% | RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days | 0 | 157 | 2 | 157 | 19 | 157 |
| EG001 | Vehicle Ophthalmic Solution | Vehicle placebo ophthalmic solution One drop each eye QD for 84 days | 0 | 77 | 0 | 77 | 5 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MeDRA 21.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MeDRA 21.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MeDRA 21.0 | Non-systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MeDRA 21.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MeDRA 21.0 | Non-systematic Assessment |
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| Vital dye staining cornea present | Investigations | MeDRA 21.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MeDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Clinical Operations | RVL Pharmaceuticals, Inc. | 908-809-1423 | mvelasco@osmotica.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2018 | Aug 4, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| >=65 years |
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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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