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The objective of this study is to evaluate the IOP-lowering effect when subjects are switched from various latanoprost-based regimens to Rocklatan. Subjects will stop their IOP-lowering medical therapy regimen and dose with Rocklatan for the duration of the study (12 weeks).
Enrollment will be stratified according to subject's IOP-lowering medical therapy regimen as follows:
Aerie Pharmaceuticals was acquired by Alcon Research LLC on November 22, 2022.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocklatan | Experimental | Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution | Drug | Commercially available ophthalmic solution indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12 | IOP was measured using Goldmann applanation tonometry at the Baseline and Week 12 visits. One eye (study eye) contributed data to this analysis. A negative value indicates an improvement in IOP. No hypothesis testing was prespecified for this endpoint. | Baseline (Day 0 pretreatment), Week 12 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scientific Advisor, Clinical R&D | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Valley Eye Medical Group | Mission Hills | California | 91345 | United States | ||
| Visionary Eye Institute |
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This reporting population includes all participants who received at least 1 dose of study medication.
Participants were recruited from 21 investigative sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rocklatan (Latanoprost Mono) | Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost Mono medical therapy regimen) |
| FG001 | Rocklatan (Latanoprost +1) |
| 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 | Sep 30, 2022 | Mar 8, 2024 |
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|
| Newport Beach |
| California |
| 92663 |
| United States |
| California Eye Specialists Medical Group | Pasadena | California | 91107 | United States |
| North Bay Eye Associates | Petaluma | California | 94954 | United States |
| Shettle Eye Research | Largo | Florida | 33773 | United States |
| Center For Sight | Venice | Florida | 34285 | United States |
| Georgia Eye Partners | Atlanta | Georgia | 30342 | United States |
| Coastal Research Associates LLC | Roswell | Georgia | 30076 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| OCLI Vision | Manhasset | New York | 11030 | United States |
| Mark J. Weiss, MD, Inc. | Tulsa | Oklahoma | 74104 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Advancing Vision Research | Goodlettsville | Tennessee | 37072 | United States |
| VRF Eye Specialty Group | Memphis | Tennessee | 38120 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38199 | United States |
| Keystone Research | Austin | Texas | 78731 | United States |
| Louis M. Alpern, M.D., M.P.H., P.A | El Paso | Texas | 79902 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Emerson Clinical Research Institute | Falls Church | Virginia | 22046 | United States |
| Vistar Eye Center | Roanoke | Virginia | 24016 | United States |
| The Eye Centers of Racine and Kenosha | Racine | Wisconsin | 53405 | United States |
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen) |
| FG002 | Rocklatan (Latanoprost +2) | Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen) |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population: All subjects who have received at least 1 dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Rocklatan (Latanoprost Mono) | Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost mono medical therapy regimen) |
| BG001 | Rocklatan (Latanoprost +1) | Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen) |
| BG002 | Rocklatan (Latanoprost +2) | Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen) |
| BG003 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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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 Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12 | IOP was measured using Goldmann applanation tonometry at the Baseline and Week 12 visits. One eye (study eye) contributed data to this analysis. A negative value indicates an improvement in IOP. No hypothesis testing was prespecified for this endpoint. | All subjects that received at least 1 follow-up visit with a completed IOP measure and with complete data at both baseline and final visits. | Posted | Mean | Standard Deviation | percent change | Baseline (Day 0 pretreatment), Week 12 |
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Adverse events (AEs) were collected for the duration of individual participation in the study, approximately 12 weeks (±7 days).
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered related to the study medication. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. This analysis population includes subjects who have received at least 1 dose of study medication.
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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 | Rocklatan (Latanoprost Mono) | Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost mono medical therapy regimen) | 0 | 61 | 0 | 61 | 9 | 61 |
| EG001 | Rocklatan (Latanoprost +1) | Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen) | 0 | 45 | 0 | 45 | 10 | 45 |
| EG002 | Rocklatan (Latanoprost +2) | Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen) | 0 | 30 | 1 | 30 | 6 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Advisor, Clinical R&D | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2022 | Mar 8, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000603944 | netarsudil |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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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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| Black or African American |
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| White |
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| Other |
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