Clinical trial NCT03233308: Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Official title: A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment With Netarsudil Ophthalmic Solution 0.02% (AR-13324) in Subjects With Elevated Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma or Ocular Hypertension
Keywords: Aqueous Humor Dynamics
Trabecular Outflow
Netarsudil
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paired comparison study
Primary purpose: TREATMENT

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. Netarsudil treatment was given in one eye and placebo given in contralateral eye for 7 consecutive days.

Eligibility criteria: Inclusion Criteria:

1. Must be 18 years of age or older
2. Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
3. Unmedicated intraocular pressure (IOP) \>20 mmHg and \< 30 mmHg in both eyes at first qualification visit
4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
5. Able to give informed consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
3. Intraocular pressure ≥30 mmHg in either eye
4. A difference in IOP between eyes \>4mmHg at qualification visit
5. Use of more than two ocular hypotensive medications within 30 days of screening
6. Known hypersensitivity to any component of the formulation
7. Previous glaucoma surgery or refractive surgery
8. Keratorefractive surgery in either eye
9. 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
10. Recent or current ocular infection or inflammation in either eye
11. Use of ocular medication in either eye of any kind within 30 days of screening
12. Mean central corneal thickness greater than 620 μm in either eye
13. Any abnormality preventing reliable applanation tonometry of either eye
14. Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)

    Systemic:
15. Clinically significant abnormalities within 6 weeks prior to screening
16. Clinically significant systemic disease
17. Participation in any investigational study within 60 days prior to screening
18. Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
19. Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

Primary outcomes:
measure: Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility
timeFrame: Study treatment was administered for 7 days, and outcome measures collected on Day 8
measure: Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.
timeFrame: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Secondary outcomes:
measure: Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
timeFrame: Study treatment was administered for 7 days, and outcome measures collected on Day 8
measure: Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
timeFrame: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Aerie Pharmaceuticals
name: Nancy Ramirez-Davis
role: STUDY_DIRECTOR
References: