Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
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.
Interventions
1 drop in each eye once daily in the evening
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female subjects (aged 18 or older) 2. Subjects diagnosed with open-angle glaucoma or ocular hypertension, and determined by the treating physician to require additional intraocular pressure (IOP)-lowering treatment with netarsudil 0.02%. 3. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing questionnaires and completing laboratory tests Key
Exclusion criteria
1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation 2. Women of childbearing potential who are pregnant, nursing, or planning a pregnancy and not using a medically acceptable form of birth control. Male subjects with a female partner of childbearing potential must have had a prior vasectomy or agree to use an effective method of birth control during the treatment period and for 3 months after the subject has completed the study. 3. Known sensitivity or allergy to the study medication or components 4. Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results 5. Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) | 12 weeks | Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC). |
Countries
United States
Participant flow
Recruitment details
A total of 261 subjects were enrolled across 22 investigational sites and 260 treated.
Pre-assignment details
The enrolled population includes all subjects who signed ICF. One subject enrolled but withdrew consent before study drug dispensed; thus, post-baseline treatment is unavailable. Participant Flow data represents ITT population. Clarification of enrolled (n= 261) vs treated (n=260) subjects is provided in Recruitment & Pre-assignment sections.
Participants by arm
| Arm | Count |
|---|---|
| Netarsudil Ophthalmic Solution 0.02% Monotherapy Netarsudil Ophthalmic Solution 0.02% Monotherapy - 1 drop in each eye once daily in the evening. | 91 |
| Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening. | 151 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 17 |
| Overall Study | Intolerance to Conjunctival Hyperemia | 1 | 0 |
| Overall Study | IOP Too High | 1 | 1 |
| Overall Study | IOP Too High, Nerve/Visual Field Changes | 0 | 1 |
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Medication Non-Compliance | 0 | 1 |
| Overall Study | Visit Out of Window | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy | Total | Netarsudil Ophthalmic Solution 0.02% Monotherapy |
|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 10.53 | 67.2 years STANDARD_DEVIATION 11.02 | 67.2 years STANDARD_DEVIATION 11.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 19 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 143 Participants | 223 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants | 58 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 102 Participants | 179 Participants | 77 Participants |
| Sex: Female, Male Female | 91 Participants | 148 Participants | 57 Participants |
| Sex: Female, Male Male | 60 Participants | 94 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 161 |
| other Total, other adverse events | 43 / 99 | 58 / 161 |
| serious Total, serious adverse events | 2 / 99 | 1 / 161 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Netarsudil Ophth Sol 0.02% Monotherapy - Tx Naïve At Baseline | Intraocular Pressure (IOP) | -16.9 percent change | Standard Deviation 16.35 |
| Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 1 Agent | Intraocular Pressure (IOP) | -2.3 percent change | Standard Deviation 16.23 |
| Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 2 Agents | Intraocular Pressure (IOP) | 0.2 percent change | Standard Deviation 8.81 |
| Netarsudil Ophth Sol 0.02% Concomitant Therapy | Intraocular Pressure (IOP) | -17.0 percent change | Standard Deviation 16.81 |
Comparison: Cohorts assessed versus baseline treatment