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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Must be 18 years of age or older
  2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes
  3. Unmedicated intraocular pressure >20 mmHg and < 30 mmHg in both eyes at first qualification visit
  4. Corrected visual acuity equivalent to 20/200
  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. 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
  9. Recent or current ocular infection or inflammation in either eye
  10. Use of ocular medication in either eye of any kind within 30 days of screening
  11. Mean central corneal thickness greater than 620 μm in either eye
  12. Any abnormality preventing reliable applanation tonometry of either eye

Systemic:

  1. Clinically significant abnormalities in any recent laboratory tests within 6 weeks prior to screening
  2. Clinically significant systemic disease
  3. Participation in any investigational study within 60 days prior to screening
  4. Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
  5. Women who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Arthur Sit, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20346676

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