Status:
COMPLETED
Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Lead Sponsor:
Aerie Pharmaceuticals
Conditions:
Primary Open Angle Glaucoma or Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo
Detailed Description
Trabecular outflow facility is a measure of aqueous humor dynamics; effect of netarsudil on this parameter as well as on intraocular pressure and episcleral venous pressure was evaluated in this study...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03233308
Start Date
October 20 2017
End Date
April 19 2018
Last Update
August 6 2019
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Duke Eye Center
Durham, North Carolina, United States, 27710