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

Last updated: May 13, 2019
Sponsor: Aerie Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Glaucoma

Ocular Hypertension

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT02558400
PG324-CS301
  • Ages > 18
  • All Genders

Study Summary

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.

Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years of age or older

  2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes

  3. Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualificationvisits. Both eyes had to qualify at all qualification visits

  4. Corrected visual acuity equivalent to 20/200 Snellen or better

  5. Able to give informed consent and follow study instructions

Exclusion

Exclusion Criteria:

  1. Clinically significant ocular disease

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

  3. Unmedicated Intraocular pressure ≥36mmHg

  4. Use of more than 2 ocular hypotensive medications within 30 days of screening

  5. Known hypersensitivity to any component of the formulation

  6. Previous glaucoma surgery or refractive surgery

  7. Ocular trauma within 6 months prior to screening

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

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

  10. Used ocular medication in either eye of any kind within 30 days of screening

  11. Mean central corneal thickness >620µm at screening

  12. Any abnormality preventing reliable applanation tonometry of either eye

  13. Clinically significant abnormalities in lab tests at screening

  14. Clinically significant systemic disease

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

  16. Used any systemic medication that could have a substantial effect on intraocularpressure within 30 days prior to screening

  17. Women who are pregnant, nursing, planning a pregnancy or not using a medicallyacceptable form of birth control

Study Design

Total Participants: 718
Study Start date:
September 18, 2015
Estimated Completion Date:
June 30, 2017

Connect with a study center

  • Aerie Pharmaceuticals

    Bedminster, New Jersey 07921
    United States

    Site Not Available

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