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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

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ClinicalTrials.gov Identifier: NCT03284853
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: Netarsudil/Latanoprost 0.02%/0.005% Drug: GANFORT® Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 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)
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019


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

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




Primary Outcome Measures :
  1. Mean diurnal Intraocular Pressure by Goldmann Applanation Tonometry [ Time Frame: Day 90 ]

Secondary Outcome Measures :
  1. Assessment of anterior segment tissues by slit lamp biomicroscopy [ Time Frame: 6 months ]
  2. Assessment of posterior segment tissues by dilated ophthalmoscopy [ Time Frame: 6 months ]
  3. Systemic safety of vital signs (heart rate/bpm) [ Time Frame: 6 months ]
  4. Systemic safety of vital signs (blood pressure/systolic diastolic mmHg) [ Time Frame: 6 months ]
  5. Systemic safety clinical laboratory assessments (hematology and clinical chemistry) [ Time Frame: 6 months ]
  6. Assessment of Intraocular Pressure [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or equal to 17 mmHg and less than 28 mmHg in both eyes at screening visit
  5. Unmedicated (post-washout) IOP greater than 20mmHg in at least one eye and less than 36mmHg in both eyes at two qualification visits. At 2nd qualification visit to have IOP greater than 17mmHg in at least one eye and less than 36mmHg in both eyes. If only one eye qualifies at 2nd qualification visit it MUST be the same eye qualified on the 1st visit (this will be known as the study eye).
  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 (NOTE - fixed dose combinations, for the purpose of this exclusion criterion count as one medication); however subjects currently taking 2 fixed dose combination products are excluded.
  4. Treatment-naïve subjects
  5. Prior treatment with GANFORT® topical eye drops, where subjects IOP did not achieve target IOP and was considered a failure or an insufficient response. Subjects currently (prior to screening visit) being treated with GANFORT® are excluded from the study.
  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 (which must be the same medication for 30 days prior to screening) 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 (including corticosteroids) that could have a substantial effect on IOP which HAVE NOT been maintained at a consistent dose and regime within 30 days prior to screening, and are anticipated to change in dose and/or regime during the study
  19. Use of topical steroids containing medications on the face or in or around the eyes will exclude the subject
  20. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable and highly effective form of birth control
  21. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284853


Contacts
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Contact: Mark Herring 888-594-5111 mercury3@aeriepharma.com

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Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Mark Herring Aerie Pharmaceuticals Ireland Ltd.

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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03284853     History of Changes
Other Study ID Numbers: PG324-CS303
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
Bimatoprost
Timolol
Cloprostenol
Antihypertensive Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents