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

Primary Open Angle Glaucoma or Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233308
• Other study ID #: AR-13324-CS206
• Status: Completed
• Phase: Phase 2
• Start date: October 20, 2017
• Est. completion date: April 19, 2018

Study information

• Verified date: July 2019
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 19, 2018
• Est. primary completion date: April 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma or Ocular Hypertension

Intervention

Drug:
• Netarsudil Ophthalmic Solution 0.02%
1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye

Other:
• Placebo Comparator
1 drop daily (QD), in the morning (AM) of Placebo comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility	Mean diurnal change from baseline in trabecular (tonographic) outflow facility.	Study treatment was administered for 7 days, and outcome measures collected on Day 8
Primary	Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.	Mean diurnal change from baseline in trabecular (tonographic) outflow facility.	Study treatment was administered for 7 days, and outcome measures collected on Day 8
Secondary	Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)	Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)	Study treatment was administered for 7 days, and outcome measures collected on Day 8
Secondary	Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)	Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)	Study treatment was administered for 7 days, and outcome measures collected on Day 8