Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Sponsor
Aerie Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02057575
Collaborator
(none)
298
23
4
5
13
2.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
298 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date
:
Jan 1, 2014
Actual Primary Completion Date
:
Jun 1, 2014
Actual Study Completion Date
:
Jun 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PG324 Ophthalmic Solution 0.01% Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution |
Drug: PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
| Experimental: PG324 Ophthalmic Solution 0.02% Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution |
Drug: PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
| Active Comparator: Netarsudil (AR-13324) Ophthalmic Solution 0.02% Netarsudil 0.02% ophthalmic solution |
Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
| Active Comparator: Latanoprost Ophthalmic Solution 0.005% Latanoprost 0.005% ophthalmic solution |
Drug: Latanoprost Ophthalmic Solution 0.005%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Outcome Measures
Primary Outcome Measures
- Intraocular Pressure (IOP) [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kenneth Sall, M.D. | Artesia | California | United States | 90701 |
| 2 | United Medical Research Institute | Inglewood | California | United States | 90301 |
| 3 | Aesthetic Eye Care Institute | Newport Beach | California | United States | 92657 |
| 4 | Bacharach practice | Petaluma | California | United States | 94954 |
| 5 | Centre For Health Care | Poway | California | United States | 92064 |
| 6 | Clayton Eye Center | Morrow | Georgia | United States | 30260 |
| 7 | Coastal Research Associates, LLC | Roswell | Georgia | United States | 30076 |
| 8 | Bradley Kwapiszeski, MD | Shawnee Mission | Kansas | United States | 66204 |
| 9 | Taustine Eye Center | Louisville | Kentucky | United States | 40217 |
| 10 | Seidenberg Protzko Eye Associates | Havre De Grace | Maryland | United States | 21078 |
| 11 | Great Lakes Eye Care | Saint Joseph | Michigan | United States | 49085 |
| 12 | Comprehensive Eye Care | Saint Louis | Missouri | United States | 63090 |
| 13 | Ophthalmic Consultants of Long Island | Lynbrook | New York | United States | 11563 |
| 14 | Rochester Ophthalmological Group | Rochester | New York | United States | 14618 |
| 15 | Charlotte Eye Ear Nose & Throat Associates, P.A. | Belmont | North Carolina | United States | 28012 |
| 16 | Michael E. Tepedino, M.D. | High Point | North Carolina | United States | 27262 |
| 17 | The Eye Institute | Tulsa | Oklahoma | United States | 74104 |
| 18 | Texan Eye | Austin | Texas | United States | 78731 |
| 19 | Glaucoma Associates of Texas - Dallas Office | Dallas | Texas | United States | 75231 |
| 20 | Cataract & Glaucoma Center | El Paso | Texas | United States | 79902 |
| 21 | Medical Center Ophthalmology Associates | San Antonio | Texas | United States | 78240 |
| 22 | Stacy R. Smith, M.D. | Salt Lake City | Utah | United States | 84117 |
| 23 | Virginia Eye Consultants | Norfolk | Virginia | United States | 23502 |
Sponsors and Collaborators
- Aerie Pharmaceuticals
Investigators
- Study Director: Nancy Ramirez, M.S., Aerie Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02057575
Other Study ID Numbers:
- PG324-CS201
First Posted:
Feb 7, 2014
Last Update Posted:
Jun 4, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aerie Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Latanoprost Ophthalmic Solution 0.005% |
|---|---|---|---|---|
| Arm/Group Description | PG324 Ophthalmic Solution 0.01% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | PG324 Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | Netarsudil (AR-13324) Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | Latanoprost Ophthalmic Solution 0.005% 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
| Period Title: Overall Study | ||||
| STARTED | 74 | 73 | 78 | 73 |
| COMPLETED | 73 | 69 | 78 | 72 |
| NOT COMPLETED | 1 | 4 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Latanoprost Ophthalmic Solution 0.005% | Total |
|---|---|---|---|---|---|
| Arm/Group Description | PG324 Ophthalmic Solution 0.01% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | PG324 Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | Netarsudil (AR-13324) Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | Latanoprost Ophthalmic Solution 0.005% 1 drop daily in the evening (PM), once daily (QD), both eyes (OU) | Total of all reporting groups |
| Overall Participants | 74 | 73 | 78 | 73 | 298 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
29
39.2%
|
35
47.9%
|
33
42.3%
|
28
38.4%
|
125
41.9%
|
| >=65 years |
45
60.8%
|
38
52.1%
|
45
57.7%
|
45
61.6%
|
173
58.1%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
65.4
(11.26)
|
64.2
(11.07)
|
64.8
(11.28)
|
65.1
(12.80)
|
64.9
(11.57)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
47
63.5%
|
39
53.4%
|
43
55.1%
|
46
63%
|
175
58.7%
|
| Male |
27
36.5%
|
34
46.6%
|
35
44.9%
|
27
37%
|
123
41.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
15
20.3%
|
20
27.4%
|
15
19.2%
|
14
19.2%
|
64
21.5%
|
| Not Hispanic or Latino |
59
79.7%
|
53
72.6%
|
63
80.8%
|
59
80.8%
|
234
78.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
1.3%
|
0
0%
|
1
0.3%
|
| Asian |
3
4.1%
|
1
1.4%
|
2
2.6%
|
1
1.4%
|
7
2.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
15
20.3%
|
10
13.7%
|
17
21.8%
|
12
16.4%
|
54
18.1%
|
| White |
56
75.7%
|
62
84.9%
|
58
74.4%
|
60
82.2%
|
236
79.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Intraocular Pressure (IOP) |
|---|---|
| Description | The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29. |
| Time Frame | Study treatment was administered for 28 days, and outcome measures collected on Day 29 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent to treat (mITT) population |
| Arm/Group Title | PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution | Latanoprost Ophthalmic Solution |
|---|---|---|---|---|
| Arm/Group Description | PG324 Ophthalmic Solution 0.01% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | PG324 Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | Netarsudil (AR-13324) Ophthalmic Solution 1 drop in the evening (PM), once daily (QD), both eyes (OU) | Latanoprost Ophthalmic Solution 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
| Measure Participants | 73 | 72 | 78 | 73 |
| Day 1, Diurnal Mean |
25.11
(2.330)
|
25.12
(2.374)
|
25.35
(2.666)
|
25.99
(2.828)
|
| Day 29, Diurnal Mean |
17.33
(2.770)
|
16.52
(2.992)
|
19.13
(3.219)
|
18.44
(2.565)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PG324 Ophthalmic Solution 0.01%, Netarsudil (AR-13324) Ophthalmic Solution |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | PG324 0.01% vs netarsudil | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PG324 Ophthalmic Solution 0.02%, Netarsudil (AR-13324) Ophthalmic Solution |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | PG324 0.02% vs. netarsudil | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PG324 Ophthalmic Solution 0.01%, Latanoprost Ophthalmic Solution |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | PG324 0.01% vs. latanoprost | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PG324 Ophthalmic Solution 0.02%, Latanoprost Ophthalmic Solution |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | PG324 0.02% vs. latanoprost | |
Adverse Events
| Time Frame | Adverse Event Data was collected over the course of the study of the 28 day treatment period | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections) | |||||||
| Arm/Group Title | PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution | Latanoprost Ophthalmic Solution | ||||
| Arm/Group Description | PG324 Ophthalmic Solution 0.01% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | PG324 Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | Netarsudil (AR-13324) Ophthalmic Solution 1 drop in the evening (PM), once daily (QD), both eyes (OU) | Latanoprost Ophthalmic Solution Latanoprost Ophthalmic Solution: 1 drop daily (evening) | ||||
All Cause Mortality |
||||||||
| PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution | Latanoprost Ophthalmic Solution | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/74 (0%) | 0/73 (0%) | 0/78 (0%) | 0/73 (0%) | ||||
Serious Adverse Events |
||||||||
| PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution | Latanoprost Ophthalmic Solution | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/74 (0%) | 0/73 (0%) | 0/78 (0%) | 3/73 (4.1%) | ||||
| Eye disorders | ||||||||
| Ulcerative Keratitis | 0/74 (0%) | 0/73 (0%) | 0/78 (0%) | 1/73 (1.4%) | ||||
| Gastrointestinal disorders | ||||||||
| Large Intestine Perforation | 0/74 (0%) | 0/73 (0%) | 0/78 (0%) | 1/73 (1.4%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholecystitis Acute | 0/74 (0%) | 0/73 (0%) | 0/78 (0%) | 1/73 (1.4%) | ||||
| Infections and infestations | ||||||||
| Diverticulitis | 0/74 (0%) | 0/73 (0%) | 0/78 (0%) | 1/73 (1.4%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution | Latanoprost Ophthalmic Solution | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 46/73 (63%) | 55/73 (75.3%) | 49/78 (62.8%) | 12/73 (16.4%) | ||||
| Eye disorders | ||||||||
| Conjunctival Hyperaemia | 29/73 (39.7%) | 29 | 29/73 (39.7%) | 29 | 27/78 (34.6%) | 27 | 9/73 (12.3%) | 9 |
| Lacrimation Increased | 1/73 (1.4%) | 1 | 4/73 (5.5%) | 4 | 1/78 (1.3%) | 1 | 0/73 (0%) | 0 |
| General disorders | ||||||||
| Instillation Site Erythema | 11/73 (15.1%) | 11 | 14/73 (19.2%) | 14 | 17/78 (21.8%) | 17 | 1/73 (1.4%) | 1 |
| Instillation Site Pain | 5/73 (6.8%) | 5 | 8/73 (11%) | 8 | 4/78 (5.1%) | 4 | 2/73 (2.7%) | 2 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Theresa GH Heah, MD, MBA |
|---|---|
| Organization | Aerie Pharmaceuticals, Inc |
| Phone | 908-947-3844 |
| theah@aeriepharma.com |
Responsible Party:
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02057575
Other Study ID Numbers:
- PG324-CS201
First Posted:
Feb 7, 2014
Last Update Posted:
Jun 4, 2019
Last Verified:
May 1, 2019