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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Open-angle Glaucoma; Ocular Hypertension	Drug: PG324 Ophthalmic Solution; Drug: Netarsudil (AR-13324) Ophthalmic Solution; Drug: Latanoprost Ophthalmic Solution	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	690 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Actual Study Start Date :	September 18, 2015
Actual Primary Completion Date :	May 17, 2017
Actual Study Completion Date :	June 30, 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: PG324 Ophthalmic Solution; 1 drop daily (evening) both eyes	Drug: PG324 Ophthalmic Solution; 1 drop daily (evening) both eyes
Active Comparator: Netarsudil (AR-13324) Ophthalmic Solution; 1 drop daily (evening) both eyes	Drug: Netarsudil (AR-13324) Ophthalmic Solution; 1 drop daily (evening) both eyes
Active Comparator: Latanoprost Ophthalmic Solution; 1 drop daily (evening) both eyes	Drug: Latanoprost Ophthalmic Solution; 1 drop daily (evening) both eyes

Outcome Measures

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Primary Outcome Measures :

1. Intraocular pressure [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 months ]
2. Changes in visual acuity from baseline [ Time Frame: 12 months ]
3. Changes in visual field test from baseline [ Time Frame: 12 months ]
4. Changes in pupil size from baseline [ Time Frame: 12 months ]

Eligibility Criteria

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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. 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 1 or both eyes at qualification visits
4. Corrected visual acuity equivalent to 20/200
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
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 to screening
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 intraocular pressure within 30 days prior to screening
17. Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Contacts and Locations

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Locations

United States, New Jersey
Aerie Pharmaceuticals
Bedminster, New Jersey, United States, 07921

Sponsors and Collaborators

Aerie Pharmaceuticals

More Information

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Responsible Party:	Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02558400 History of Changes
Other Study ID Numbers:	PG324-CS301
First Posted:	September 24, 2015
Last Update Posted:	April 17, 2018
Last Verified:	January 2017

Additional relevant MeSH terms:

Pharmaceutical Solutions; Antihypertensive Agents; Hypertension; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension	Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Ophthalmic Solutions; Latanoprost