Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

Last updated: May 14, 2019
Sponsor: Aerie Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Ocular Hypertension

Vascular Diseases

Glaucoma

Treatment

N/A

Clinical Study ID

NCT02674854
PG324-CS302
  • Ages 18-99
  • All Genders

Study Summary

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years of age or older (19 years of age or older in Canada)

  2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes

  3. Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualificationvisits

  4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better

  5. Able to give informed consent and follow study instructions

Exclusion

Exclusion Criteria: Ophthalmic:

  1. Clinically significant ocular disease

  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closureor narrow angles

  3. Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocularhypotensive medications within 30 days of screening

  4. Known hypersensitivity to any component of the formulation or latanoprost

  5. Previous glaucoma surgery or refractive surgery

  6. Ocular trauma within 6 months prior to screening

  7. Any ocular surgery or non-refractive laser treatment within 3 months prior toscreening

  8. Recent or current ocular infection or inflammation in either eye

  9. Use of ocular medication in either eye of any kind within 30 days of screening andthroughout of the study

  10. Mean central corneal thickness >620µm at screening in either eye

  11. Any abnormality preventing reliable applanation tonometry of either eye Systemic:

  12. Clinically significant abnormalities in lab tests at screening

  13. Clinically significant systemic disease

  14. Participation in any investigational study within 60 days prior to screening

  15. Systemic medication that could have had a substantial effect on IOP within 30 daysprior to screening, or anticipated to be used during the study

  16. Women of childbearing potential who were pregnant, nursing, planning a pregnancy, ornot using a medically acceptable form of birth control

Study Design

Total Participants: 750
Study Start date:
February 01, 2016
Estimated Completion Date:
March 31, 2017

Connect with a study center

  • Aerie Pharmaceuticals

    Bedminster, New Jersey 07921
    United States

    Site Not Available

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