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Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT02057575
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 6, 2014
First Posted Date  ICMJE February 7, 2014
Results First Submitted Date  ICMJE March 27, 2019
Results First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 4, 2019
Study Start Date  ICMJE January 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Intraocular Pressure (IOP) [ Time Frame: Study treatment was administered for 28 days, and outcome measures collected on Day 29 ]
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Intraocular Pressure [IOP] [ Time Frame: Day 29 ]
The mean diurnal IOP across subjects within treatment group.
Change History Complete list of historical versions of study NCT02057575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
  • Intraocular Pressure [IOP] [ Time Frame: Day 8, Day 15, and Day 29 ]
    Mean IOP across subjects within treatment group at each post-treatment timepoint.
  • Intraocular Pressure [IOP] [ Time Frame: Day 8, Day 15, and Day 29 ]
    Mean change from diurnally adjusted baseline IOP at each timepoint.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Official Title  ICMJE A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure
Brief Summary To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Open Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: PG324 Ophthalmic Solution 0.01%
    1 drop in the evening (PM), once daily (QD), both eyes (OU)
  • Drug: PG324 Ophthalmic Solution 0.02%
    1 drop in the evening (PM), once daily (QD), both eyes (OU)
  • Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
    1 drop in the evening (PM), once daily (QD), both eyes (OU)
  • Drug: Latanoprost Ophthalmic Solution 0.005%
    1 drop in the evening (PM), once daily (QD), both eyes (OU)
Study Arms  ICMJE
  • Experimental: PG324 Ophthalmic Solution 0.01%
    Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
    Intervention: Drug: PG324 Ophthalmic Solution 0.01%
  • Experimental: PG324 Ophthalmic Solution 0.02%
    Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution
    Intervention: Drug: PG324 Ophthalmic Solution 0.02%
  • Active Comparator: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
    Netarsudil 0.02% ophthalmic solution
    Intervention: Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
  • Active Comparator: Latanoprost Ophthalmic Solution 0.005%
    Latanoprost 0.005% ophthalmic solution
    Intervention: Drug: Latanoprost Ophthalmic Solution 0.005%
Publications * Lewis RA, Levy B, Ramirez N, Kopczynski CC, Usner DW, Novack GD; PG324-CS201 Study Group. Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension. Br J Ophthalmol. 2016 Mar;100(3):339-44. doi: 10.1136/bjophthalmol-2015-306778. Epub 2015 Jul 24. Erratum in: Br J Ophthalmol. 2016 Jul;100(7):1016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2014)
298
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2014)
300
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or greater.
  • Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
  • Corrected visual acuity in each eye equivalent to 20/200 or better
  • Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic:

  • Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
  • Intraocular pressure >36 mmHg
  • Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
  • Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
  • Refractive surgery in study eye(s)
  • Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
  • Evidence of ocular infection and inflammation
  • Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
  • Central corneal thickness greater then 600 μm
  • Any abnormality preventing reliable applanation tonometry of either eye

Systemic:

  • Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
  • Clinically significant systemic disease
  • Participation in any investigational study within 30 days prior to screening
  • Changes in systemic medication
  • Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02057575
Other Study ID Numbers  ICMJE PG324-CS201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aerie Pharmaceuticals
Study Sponsor  ICMJE Aerie Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nancy Ramirez, M.S. Aerie Pharmaceuticals, Inc.
PRS Account Aerie Pharmaceuticals
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP