A Phase 4 interventional study of Netarsudil Ophthalmic Solution 0.02% in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Aerie Pharmaceuticals. Completed at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-29.
Sponsored by Aerie Pharmaceuticals · Phase 4, Interventional, and Treatment
To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as monotherapy or when used concomitantly with other IOP-lowering agents in subjects with elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical setting. The study is an open-label design. The patients will receive treatment for 12 weeks.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 261 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Aerie Pharmaceuticals is the lead sponsor of 35 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: Netarsudil Ophthalmic Solution 0.02%
1 drop in each eye once daily in the evening
Also known as: Rhopressa
Intraocular Pressure (IOP)
Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC).
Time frame: 12 weeks
A total of 261 subjects were enrolled across 22 investigational sites and 260 treated.
| Milestone | Netarsudil Ophthalmic Solution 0.02% Monotherapy | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy |
|---|---|---|
| Started | 99 | 161 |
| Completed | 81 | 138 |
| Not completed | 18 | 23 |
| Withdrew: Adverse event | 13 | 17 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Intolerance to conjunctival hyperemia | 1 | 0 |
| Withdrew: Iop too high | 1 | 1 |
| Withdrew: Iop too high, nerve/visual field changes | 0 | 1 |
| Withdrew: Visit out of window | 0 | 1 |
| Withdrew: Medication non-compliance | 0 | 1 |
Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC).
| percent change | Netarsudil Ophth Sol 0.02% Monotherapy - Tx Naïve At Baseline | Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 1 Agent | Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 2 Agents | Netarsudil Ophth Sol 0.02% Concomitant Therapy |
|---|---|---|---|---|
| Intraocular Pressure (IOP) | -16.9 ± 16.35 | -2.3 ± 16.23 | 0.2 ± 8.81 | -17.0 ± 16.81 |
Collected over Adverse event data was collected during the course of the 12-week treatment period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% Monotherapy | 0/99 (0%) | 2/99 (2%) | 43/99 (43.4%) |
| Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy | 0/161 (0%) | 1/161 (0.6%) | 58/161 (36%) |
| Event | Netarsudil Ophthalmic Solution 0.02% Monotherapy | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy |
|---|---|---|
| Malignant Melanoma of EyelidNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/99 | 0/161 |
| PneumoniaInfections and infestations | 1/99 | 0/161 |
| Cellulitis Lower Left ExtremityInfections and infestations | 0/99 | 1/161 |
| Event | Netarsudil Ophthalmic Solution 0.02% Monotherapy | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy |
|---|---|---|
| Conjunctival HyperemiaEye disorders | 22/99 | 32/161 |
| Vision BlurredEye disorders | 9/99 | 10/161 |
| Conjunctival HemorrageEye disorders | 6/99 | 8/161 |
| Instillation Site PainEye disorders | 6/99 | 8/161 |
Modified intent to treat (mITT) population included all subjects who received at least 1 dose of study medication and had at least 1 follow-up visit with a completed IOP measurement.
| Age, Continuous(years) | Netarsudil Ophthalmic Solution 0.02% Monotherapy | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy | Total |
|---|---|---|---|
| Mean | 67.2 ± 11.85 | 67.2 ± 10.53 | 67.2 ± 11.02 |
| Sex: Female, Male(Participants) | Netarsudil Ophthalmic Solution 0.02% Monotherapy | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy | Total |
|---|---|---|---|
| Female | 57 | 91 | 148 |
| Male | 34 | 60 | 94 |
| Ethnicity (NIH/OMB)(Participants) | Netarsudil Ophthalmic Solution 0.02% Monotherapy | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 8 | 19 |
| Not Hispanic or Latino | 80 | 143 | 223 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Netarsudil Ophthalmic Solution 0.02% Monotherapy | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 3 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 45 | 58 |
| White | 77 | 102 | 179 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Aerie Pharmaceuticals