Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Completed · Phase 2 · Has a placebo group
Conditions studied: Primary Open Angle Glaucoma or Ocular Hypertension
In brief
To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo
Key facts
- Study ID
- NCT03233308
- Run by
- Aerie Pharmaceuticals
- People needed
- 20
- Starts
- 2017-10-20
- Expected to finish
- 2018-04-19
- Last updated by the study team
- 2019-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must be 18 years of age or older
- Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
- Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first qualification visit
- Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
- Able to give informed consent and follow study instructions
You may not qualify if…
- Ophthalmic:
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
- Intraocular pressure ≥30 mmHg in either eye
- A difference in IOP between eyes >4mmHg at qualification visit
- Use of more than two ocular hypotensive medications within 30 days of screening
- Known hypersensitivity to any component of the formulation
- Previous glaucoma surgery or refractive surgery
- Keratorefractive surgery in either eye
- Report of ocular injury in either eye within the six months prior to screening or ocular or non-refractive surgery within 3 months prior to screening
- Recent or current ocular infection or inflammation in either eye
- Use of ocular medication in either eye of any kind within 30 days of screening
- Mean central corneal thickness greater than 620 μm in either eye
- Any abnormality preventing reliable applanation tonometry of either eye
- Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)
- Systemic:
- Clinically significant abnormalities within 6 weeks prior to screening
- Clinically significant systemic disease
- Participation in any investigational study within 60 days prior to screening
- Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
- Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
- Duke Eye Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.