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Phase 3 study to evaluate the safety and efficacy of treatment with 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 in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group | LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen). | Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye | The Marginal Reflex Distance (MRD) is the distance from the center pupillary light reflex to the central margin of the upper eyelid. The MRD is measured from an external photograph using a handheld caliper and a millimeter ruler label placed on the subject's forehead as a measurement legend. | Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42 |
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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 |
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Planned sample size was approximately 156 subjects, 104 subjects in the RVL-1201 group, and 52 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 once-daily in the morning |
| FG001 | Vehicle Ophthalmic Solution |
| 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 9, 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 | Mission Hills | California | 941345 | 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 Tran | Westminster | California | 92683 | United States |
| Danbury Eye Physicians | Danbury | Connecticut | 06810 | United States |
| Hernando Eye Institute | Brooksville | Florida | 34615 | United States |
| Shettle Eye Research | Largo | Florida | 33773 | United States |
| West Coast Eye | 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 | 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 | Shawnee Mission | Kansas | 66204 | United States |
| Seidenberg Protzko Eye | Havre de Grace | Maryland | 21078 | United States |
| Mississippi Eye | Ocean Springs | Mississippi | 39564 | United States |
| Silverstein Eye | Kansas City | Missouri | 64133 | United States |
| Comprehensive Eye Care | Washington | Missouri | 63090 | United States |
| Rochester Ophthalmological | Rochester | New York | 14618 | United States |
| South Shore Eye | Wantagh | New York | 11793 | United States |
| CEENTA | Charlotte | North Carolina | 28210 | United States |
| Cornerstone Eye | High Point | North Carolina | 27262 | United States |
| Quinn, Foster & Assoc. | 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 | Austin | Texas | 78681 | United States |
| Texan Eye / Keystone | Austin | Texas | 78731 | United States |
| Lake Travis Eye | Lakeway | Texas | 78734 | United States |
| R&R Research | San Antonio | Texas | 78229 | United States |
| Medical Center Ophthalmology Assocs - Keystone Research | San Antonio | Texas | 78240 | United States |
Vehicle placebo ophthalmic Solution One drop each eye once-daily in the morning
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| NOT COMPLETED |
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Intent to Treat (ITT) 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 in the morning |
| BG001 | Vehicle Ophthalmic Solution | Vehicle placebo ophthalmic Solution One drop each eye QD in the morning |
| 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 | Number | participants |
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| Iris Color OD (right eye) | Count of Participants | Participants |
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| Iris Color OS (left eye) | 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 in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group | LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen). | Intent-to-Treat (ITT) population: randomized who received at least one dose. Per-Protocol Population (PPP): ITT population with no major protocol deviations (eleven subjects were excluded). ITT analysis was conducted for the primary endpoint, with Last Observation Carried Forward (LOCF) for missing data. | Posted | Mean | Standard Deviation | Points seen | Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2) |
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| Secondary | Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye | The Marginal Reflex Distance (MRD) is the distance from the center pupillary light reflex to the central margin of the upper eyelid. The MRD is measured from an external photograph using a handheld caliper and a millimeter ruler label placed on the subject's forehead as a measurement legend. | Intent-to-Treat (ITT) population: randomized who received at least one dose. Per-Protocol Population (PPP): ITT population with no major protocol deviations (eleven subjects were excluded). ITT analysis was conducted for the primary endpoint, with Last Observation Carried Forward (LOCF) for missing data. | Posted | Mean | Standard Deviation | Millimeters (mm) | Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42 |
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Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 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% | One drop each eye QD in the morning (n=109) | 0 | 109 | 1 | 109 | 13 | 109 |
| EG001 | Vehicle Ophthalmic Solution | One drop each eye QD in the morning (n=55) | 0 | 55 | 1 | 55 | 8 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Instillation site complication | General disorders | MedDRA 21.0 | Non-systematic Assessment | Administration site conditions |
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| Vital dye straining cornea present | Investigations | MedDRA 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 | Apr 15, 2019 | 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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| OD-Brown |
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| OD-Green |
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| OD-Hazel |
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| OD-Grey |
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| OS-Brown |
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| OS-Green |
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| OS-Hazel |
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| OS-Grey |
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The primary efficacy endpoints were tested sequentially. The Day 1 Hour 6 time point was tested first and if P<0.05, the Day 14 Hour 2 time point was tested at a significance level of 0.05. If the Day 1 Hour 6 endpoint is statistically significant (at the 0.05 level) but Day 14 Hour 2 was not statistically significant (at the 0.05 level), the study will still be considered positive. |
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