Phase 2
N=12
Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution
Ocular Hypertension · Open Angle Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT02874846 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Change in Intraocular Pressure (IOP) Over Nocturnal Time Period — 22.84; 23.56; 19.38; 23.19 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Netarsudil ophthalmic solution 0.02% (Drug); Netarsudil Ophthalmic Solution Vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aerie Pharmaceuticals
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intraocular Pressure (IOP) Over Nocturnal Time Period |
22.84; 23.56; 19.38; 23.19 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
0; 0 | — |
Summary
To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older.
- Ocular hypertension or open-angle glaucoma in both eyes.
- Unmedicated intraocular pressure > 17 mmHg in one or both eyes and < 30 mmHg in both eyes.
- Corrected visual acuity in each eye equivalent to 20/200 or better.
- Able and willing to give signed informed consent and follow study instructions.
Exclusion Criteria
- Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles.
- Intraocular pressure ≥ 30 mmHg.
- Use of ocular medications within 30 days.
- Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination.
- Previous eye surgery (other than cataract).
- Ocular trauma within 6 months.
- Clinically significant ocular disease that might interfere with the study.
- Central corneal thickness greater than 620 µm.
Data sourced from ClinicalTrials.gov (NCT02874846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.