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Completed

NCT Number: NCT03233308

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

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

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Key information

Conditions

Primary Open Angle Glaucoma or Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

Netarsudil ophthalmic solution 0.02%

Drug

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

Placebo Comparator

Other

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

Primary outcomes

  1. Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility

    Time frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8

    Mean diurnal change from baseline in trabecular (tonographic) outflow facility.

  2. Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.

    Time frame: 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 outcomes

  1. Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)

    Time frame: 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)

  2. Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 28, 2017
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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