Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
NCT ID: NCT02674854
Last Updated: 2019-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
750 participants
INTERVENTIONAL
2016-02-29
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PG324 Ophthalmic Solution 0.02%/0.005%
Fixed combination of netarsudil 0.02%, latanoprost 0.005 % ophthalmic solution
PG324 Ophthalmic Solution 0.02%/0.005%
1 drop daily in the evening (PM) in both eyes (OU)
Netarsudil (AR-13324) ophthalmic solution 0.02%
Netarsudil 0.02% ophthalmic solution
Netarsudil (AR-13324) ophthalmic solution 0.02%
1 drop daily in the evening (PM) in both eyes (OU)
Latanoprost ophthalmic solution 0.005%
Latanoprost 0.005 % ophthalmic solution
Latanoprost ophthalmic solution 0.005%
1 drop daily in the evening (PM) in both eyes (OU)
Interventions
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PG324 Ophthalmic Solution 0.02%/0.005%
1 drop daily in the evening (PM) in both eyes (OU)
Netarsudil (AR-13324) ophthalmic solution 0.02%
1 drop daily in the evening (PM) in both eyes (OU)
Latanoprost ophthalmic solution 0.005%
1 drop daily in the evening (PM) in both eyes (OU)
Eligibility Criteria
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Inclusion Criteria
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 qualification visits
4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
5. Able to give informed consent and follow study instructions
Exclusion Criteria
1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
3. Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive 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 to screening
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 and throughout 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 days prior to screening, or anticipated to be used during the study
16. Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
18 Years
99 Years
ALL
No
Sponsors
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Aerie Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Theresa Heah, MD, MBA
Role: STUDY_DIRECTOR
Aerie Pharmaceuticals, Inc.
Locations
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Aerie Pharmaceuticals
Bedminster, New Jersey, United States
Countries
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References
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Walter TR, Ahmed IK et al. Ophthalmology glaucoma, 2019, pg. 1-10 https://doi.org/10.1016/j.ogla.2019.03.007
Asrani S, Bacharach J, Holland E, McKee H, Sheng H, Lewis RA, Kopczynski CC, Heah T. Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Adv Ther. 2020 Apr;37(4):1620-1631. doi: 10.1007/s12325-020-01277-2. Epub 2020 Mar 12.
Wisely CE, Sheng H, Heah T, Kim T. Effects of Netarsudil and Latanoprost Alone and in Fixed Combination on Corneal Endothelium and Corneal Thickness: Post-Hoc Analysis of MERCURY-2. Adv Ther. 2020 Mar;37(3):1114-1123. doi: 10.1007/s12325-020-01227-y. Epub 2020 Jan 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PG324-CS302
Identifier Type: -
Identifier Source: org_study_id
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