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Due to COVID-19 related restrictions it was decided to close this study
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| Name | Class |
|---|---|
| Aerie Pharmaceuticals | INDUSTRY |
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The purpose of this research study is to compare the effect of Netarsudil and Timolol on eye pressure and blood vessels of the back of the eye.
The primary objective of this clinical investigation is to compare the difference in change in retinal blood vessel density (peripapillary and macular) between netarsudil ophthalmic solution 0.02% dosed once daily (QD) and timolol maleate 0.5% dosed twice daily (BID) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT) and in normal subjects.
Primary Efficacy Endpoint The primary efficacy endpoint for this study is the change in retinal blood vessel density (peripapillary and macular) between treatment groups after 4 weeks of treatment (Visit 4 [Week 5] and Visit 6 [Week 13]).
Secondary Efficacy Endpoints The secondary efficacy endpoint for this study is change in best-corrected visual acuity (BCVA).
Safety Endpoints The safety endpoint for this study is the incidence of ocular and systemic adverse events (AEs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Netarsudil 0.02% QD | Other | 4 weeks of Netarsudil 0.02% QD, then a 4 Week washout, followed by 4 weeks of Timolol maleate 0.5% BID |
|
| Timolol maleate 0.5% BID | Other | 4 weeks of Timolol maleate 0.5% BID, then a 4 Week washout, followed by 4 weeks of Netarsudil 0.02% QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil 0.02% QD | Other | This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: netarsudil 0.02% QD and timolol maleate 0.5% BID. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in retinal blood vessel density | The primary efficacy endpoint for this study is the change in retinal blood vessel density (peripapillary and macular) between treatment groups after 4 weeks of treatment (Visit 4 [Week 5] and Visit 6 [Week 13]). | Through study completion, an average of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in best-corrected visual acuity | The secondary efficacy endpoint for this study is change in best-corrected visual acuity (BCVA). | Through study completion, an average of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ocular and systemic adverse events | The safety endpoint for this study is the incidence of ocular and systemic adverse events (AEs) | Through study completion, an average of 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Camp, MD | UCSD Shiley Eye Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000603944 | netarsudil |
| D013999 | Timolol |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Timolol maleate 0.5% BID | Other | This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: netarsudil 0.02% QD and timolol maleate 0.5% BID. |
|
| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |