Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension

ID: NCT03284853
Status: Recruiting
Phase: Phase 3
Start Date: September 05, 2017
First Submitted: August 29, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: Aerie Pharmaceuticals
Sponsors & Collaborators: Aerie Pharmaceuticals
Location: Austria, Belgium, France, Germany, Italy, Spain, United Kingdom
Conditions: Open Angle Glaucoma, Ocular Hypertension
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Study Description

Brief Summary

The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure

Detailed Description

Condition or disease Intervention/treatment Phase

Ocular Hypertension

Open Angle Glaucoma

Drug: Netarsudil/Latanoprost 0.02%/0.005%
Other Names
Drug: GANFORT®
Other Names
Phase 3

Tracking Information

First Submitted DateAugust 29, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateSeptember 05, 2017
Anticipated Completion DateApril 01, 2019
Actual Primary Completion DateApril 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Mean diurnal Intraocular Pressure by Goldmann Applanation Tonometry [Time Frame: Day 90]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Assessment of anterior segment tissues by slit lamp biomicroscopy [Time Frame: 6 months]

  • Assessment of posterior segment tissues by dilated ophthalmoscopy [Time Frame: 6 months]

  • Systemic safety of vital signs (heart rate/bpm) [Time Frame: 6 months]

  • Systemic safety of vital signs (blood pressure/systolic diastolic mmHg) [Time Frame: 6 months]

  • Systemic safety clinical laboratory assessments (hematology and clinical chemistry) [Time Frame: 6 months]

  • Assessment of Intraocular Pressure [Time Frame: 6 months]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSafety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension
Official TitleA Prospective, Double-masked, Randomized, Multicenter, Active-controlled, Parallel-group, 6-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to GANFORT® (Bimatoprost 0.03% / Timolol 0.5%) Ophthalmic Solution in Subjects With Elevated Intraocular Pressure (MERCURY 3)
Brief Summary

The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
472
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Ocular Hypertension
Open Angle Glaucoma
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Netarsudil/Latanoprost 0.02%/0.005%

Topical sterile ophthalmic solution

Other Names
Drug: GANFORT®

Topical sterile ophthalmic solution

Other Names
Study Groups/Cohorts
Netarsudil/Latanoprost 0.02%/0.005%
PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.0005%) one drop daily to each eye for 180 days.

GANFORT®
GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.

Study Arms
Active Comparator GANFORT®
GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.
Drug : GANFORT®
Topical sterile ophthalmic solution

Experimental Netarsudil/Latanoprost 0.02%/0.005%
PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.0005%) one drop daily to each eye for 180 days.
Drug : Netarsudil/Latanoprost 0.02%/0.005%
Topical sterile ophthalmic solution

Arm Intervention/Treatment
Active Comparator GANFORT®
GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.
Drug : GANFORT®
Experimental Netarsudil/Latanoprost 0.02%/0.005%
PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.0005%) one drop daily to each eye for 180 days.
Drug : Netarsudil/Latanoprost 0.02%/0.005%

Recruitment Information

Recruitment Status:Recruiting
Enrollment472
Completion DateApril 01, 2019
Eligibility Criteria: Inclusion Criteria:
1. Must be 18 years or older
2. Diagnosis of Open Angle Glaucoma or Ocular Hypertension
3. Participants insufficiently controlled and/or considered in need for combination therapy
4. Medicated intraocular pressure (IOP) greater than 18 mmHg and less than 25 mmHg in both eyes at screening visit
5. Unmedicated (post-washout) IOP greater than 20mmHg and less than 36mmHg in both eyes at two qualification visits
6. Best corrected visual acuity +1.0 logMAR or better
7. Be willing and able to give informed consent and follow instructions
8. Women must be either of non-child bearing potential, or women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
9. Women of child bearing potential must have a negative urine pregnancy test within 7 days of first dose of study treatment and agree to use highly effective contraception from time of randomization and for 3 months after last dose of study medication
10. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of randomization and for 3 months following the last dose of study medication
11. In France, a subject will be eligible for inclusion in this study only if either affiliated to or as a beneficiary of a social security number

Exclusion Criteria:
Ophthalmic
1. Clinically significant ocular disease which might interfere with interpretation of the study results, including subjects with glaucomatous damage so severe that washout of ocular hypotensive medication for four weeks or longer would not be judged as safe
2. Pseudoexfoliation or pigment dispersion glaucoma, history of narrow angles or angle closure glaucoma. Previous laser peripheral iridotomy is not permitted
3. IOP greater than or the same as 36mmHg (unmedicated) in either eye or the use of more than two ocular hypotensive medications within 30 days of screening
4. Treatment-naïve subjects
5. Prior treatment with GANFORT® topical eye drops
6. Known hypersensitivity to any component of the investigational formulations to be used
7. Previous glaucoma intra ocular surgery
8. Refractive surgery in either eye
9. Ocular trauma within 6 months prior to screening, or ocular surgery or non- refractive laser treatment within 3 months prior to screening
10. Recent or current evidence of ocular infection or inflammation in either eye.
11. Use of ocular medication in either eye within 30 days of screening and throughout the study with the exception of permitted ocular medication as prescribed by the investigator
12. Mean central corneal thickness greater than 620μm at screening
13. Any abnormality preventing reliable Goldmann applanation tonometry of either eye
Systemic
14. Clinically significant abnormalities in laboratory tests at screening
15. Known hypersensitivity or contraindication to GANFORT® and to β-adrenoceptor antagonists
16. Clinically significant systemic disease which might interfere with the study
17. Participation in any investigational study within 30 days prior to screening
18. Systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study
19. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable and highly effective form of birth control
20. Vulnerable subjects such as minors, adults under legal protection or unable to express their consent, persons deprived of liberty or persons subject to psychiatric care
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Austria
Belgium
France
Germany
Italy
Spain
United Kingdom

Administrative Information

NCT Number:NCT03284853
Other Study ID Numbers
PG324-CS303
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Aerie Pharmaceuticals
Collaborators
Not Available
Investigators
Study Director
Mark Herring
Aerie Pharmaceuticals Ireland Ltd.