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

Phase 2

Completed

• Conditions: Primary Open Angle Glaucoma or Ocular Hypertension
• Interventions: Drug: Netarsudil Ophthalmic Solution 0.02%; Other: Placebo Comparator

• Registration Number: NCT03233308
• Lead Sponsor: Aerie Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-28
• Study Start: 2017-10-20
• Primary Completion: 2018-04-19
• Study Completion: 2018-04-19
• Results First Submitted: 2019-04-18
• Results First Submitted QC: 2019-05-20
• Results First Posted: 2019-06-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Netarsudil Ophthalmic Solution 0.02%	Placebo Comparator	Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye
Netarsudil Ophthalmic Solution 0.02%	Netarsudil Ophthalmic Solution 0.02%	Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye
Placebo Comparator	Placebo Comparator	Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye
Placebo Comparator	Netarsudil Ophthalmic Solution 0.02%	Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye

Primary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.	Study treatment was administered for 7 days, and outcome measures collected on Day 8	Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility	Study treatment was administered for 7 days, and outcome measures collected on Day 8	Mean diurnal change from baseline in trabecular (tonographic) outflow facility.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)	Study treatment was administered for 7 days, and outcome measures collected on Day 8	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)
Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)	Study treatment was administered for 7 days, and outcome measures collected on Day 8	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)

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States