Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Aerie Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Primary Open Angle Glaucoma or Ocular Hypertension

Treatments: Drug: Netarsudil Ophthalmic Solution 0.02%; Other: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03233308

AR-13324-CS206

Details and patient eligibility

About

To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Netarsudil Ophthalmic Solution 0.02%

Experimental group

Description:

Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye

Treatment:

Other: Placebo Comparator

Drug: Netarsudil Ophthalmic Solution 0.02%

Placebo Comparator

Placebo Comparator group

Description:

Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye

Treatment:

Other: Placebo Comparator

Drug: Netarsudil Ophthalmic Solution 0.02%