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

Sponsor
Aerie Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03284853
Collaborator
(none)
436
68
2
38
6.4
0.2

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
436 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 :
Sep 5, 2017
Actual Primary Completion Date :
Nov 6, 2020
Actual Study Completion Date :
Nov 6, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry [Day 90]

    Comparison of PG324 to Ganfort for mean intraocular pressure at specified timepoints at Week 2, Week 6 and Month 3.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Must be 18 years of age or older.

  2. Diagnosis of OAG or OHT in both eyes (OAG in one eye and OHT in the fellow eye is acceptable).

  3. Subjects insufficiently controlled and/or subjects considered in need for combination therapy by the investigators.

  4. Medicated intraocular pressure ≥ 17 mmHg in at least one eye and < 28mmHg in both eyes at screening visit.

  5. Unmedicated (post-washout) IOP >20mmHg in at least one eye and < 36mmHg in both eyes at 2 qualification visits at 08:00 hour, 2-7 days apart. At the second qualification visit, have IOP >17mmHg in at least one eye and < 36mmHg in both eyes at 10:00 and 16:00 hours. Note: For purposes of determining eligibility of subjects to be enrolled, the non-integral IOP mean number will be used. Any non-integral mean IOP number should not be rounded. If only one eye qualifies at the second qualification visit it MUST be the same eye that qualified on the first visit and this will be the study eye for the duration of the study.

  6. Best corrected visual acuity +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200 or better Snellen visual acuity in each eye).

  7. Be able and willing to give signed informed consent and follow study instruction.

  8. Women must be either of non-childbearing potential, or women with childbearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.

  9. Women of childbearing potential must have a negative urine pregnancy test within 7 days of first dose of study treatment and agree to use highly effective contraception during the study and for 3 months after the 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 an effective form of 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 (e.g., corneal edema, uveitis, or severe keratoconjunctivitis sicca) which might interfere with interpretation of the study efficacy endpoints or with safety assessments, including subjects with glaucomatous damage so severe that washout of ocular hypotensive medications for 4 weeks or longer if needed is not judged safe as it would put the subject at risk for further vision loss.

  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles i.e. Grade 2 Shaffer (Chan 1981) or less extreme narrow angle with complete or partial closure. Note: Previous laser peripheral iridotomy is NOT acceptable.

  3. Intraocular pressure ≥ 36mmHg (unmedicated) in either eye (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combination medications, 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 the subjects IOP did not achieve the target IOP and was considered either a therapeutic failure or to have insufficient response. Subjects currently (immediately 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 (e.g., benzalkonium chloride) or to fluorescein.

  7. Previous glaucoma intraocular surgery, including SLT or ALT in either eye.

  8. Refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, corneal cross-linking, keratoplasty).

  9. Ocular trauma within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening.

  10. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, keratitis, current evidence or history of herpes simplex or zoster keratitis in either eye at screening.

  11. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study, with the exception of a) ocular hypotensive medications which must have been the same medication for 30 days prior to screening (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after, screening), c) lubricating drops for dry eye (which may be used throughout the study), 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 (e.g., keratoconus).

Systemic:
  1. Clinically significant abnormalities in laboratory tests at screening.

  2. Known hypersensitivity or contraindication to GANFORT® (Appendix 3 Marketed Product Medication Information Section 4.3) and to β-adrenoceptor antagonists (e.g. Chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third-degree heart block or congestive heart failure, cardiac failure, cardiac shock and severe diabetes).

  3. Clinically significant systemic disease which might interfere with the study.

  4. Participation in any investigational study within 30 days prior to screening.

  5. Systemic medication including corticosteroid containing drugs 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.

  6. Use of topical steroid containing medications on the face or in or around the eyes will exclude the subject (see Section 5.6 Concomitant Medications).

  7. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable and highly effective form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal (1 year without menses with appropriate clinical profile, e.g. age appropriate, > 45 years in the absence of HRT. In questionable cases the subject must have FSH value > 40mIU/mL and an estradiol value < 40pg/mL (< 140pmol/L)) or three months post-surgical sterilization.

  8. Vulnerable subjects such as minors, adults under legal protection or unable to express their consent (e.g. hospitalized persons in coma), persons deprived of liberty (prisoners from jails), or persons subject to psychiatric care.

Contacts and Locations

Locations

Site City State Country Postal Code
1 State Hospital - University Medical Center Academical Department of Ophthalmology Graz Austria
2 Albertgasse 39/10+11 Vienna Austria
3 Hanusch Hospital Vienna Austria
4 UZ Leuven, campus Gasthuisberg, Herestraat 49, 3000 Leuven Leuven Belgium
5 Faculty Hospital Brno Eye Department Brno Czechia 62500
6 Glaucoma center Oční klinika VFN a 1. LF UK Praha Czechia 12808
7 Ophthalmology Service Centre Francois Xavier Michelet CHU Pellegrin Bordeaux France
8 Centre ophtalmologique Pole vision val d'ouest Ecully France
9 Ophthalmology Service - Batiment R Hospital de la Croix-Rousse Lyon France
10 CHU de Nantes-Hospital Hotel Dieu Ophthalmology Service Nantes France
11 Ophthalmology department Necker University Hospital-Enfants Malades Paris France
12 University Medical Center Freiburg, Eye Center,Killianstr.5, Freiburg i. Breisgau Freiburg Germany 79106
13 Department of Ophthalmology Clinical Johannes Gutenberg-University Mainz Mainz Germany
14 Universitats-Augenklinik, Studienzentrum/Clinical Trials in Opthalmology (CTO) Münster Germany
15 University Eye Hospital Tuebingen, STC eyetrial at the center for Ophthalmolgy Tuebingen Germany
16 Augenarztpraxis Dr. Andreas Bayer Weilheim Germany
17 Budapest Retina Associates Budapest Hungary
18 Department of Ophthalmology Semmelweis University Budapest Hungary
19 University of Debrecen, Clinical Center, Ophthalmology Department Debrecen Hungary
20 Clinexpert Gyongyos Kft. Heves Hungary
21 Ganglion Medical Center Pécs Hungary
22 University of Szeged, Department of Ophthalmology Szeged Hungary
23 Markusovszky University Teaching Hospital Szombathely Hungary
24 Ophthalmic Clinic DiNOGMI University Hospital San Martino Genova Italy
25 Dept. Ophthalmology, San Raffaele Hospital Milano Italy
26 ASST Fatebenefratelli Sacco P.O.L.Sacco Milan Italy
27 ASST Santi Paolo e Carlo - Ophthalmic Clinic Milan Italy
28 Department of Medicine and Surgery University of Parma Parma Italy
29 Ophthamic Clinic of the University of Pavia, IRCCS Foundation San Matteo Policlinic Pavia Italy
30 AOU Pisana Hospital of Cisanello Pisa Italy
31 G.B.Bietti Foundation - IRCCS Rome Italy
32 Senese University Hospital Siena Italy
33 S.C.U Oculistica, Azienda Ospedaliero Universitaria, Città della Salute e della Scienza Torino Italy 10146
34 University Eye Clinic Ospedale Maggiore Trieste Italy
35 Politecnico Gianbattista Rossi AOUI Ospedale Borgo Roma Verona Italy
36 Signes Ozolinas Doctor Practice in Ophthalmology Jelgava Latvia
37 Latvian American Eye Centre (LAAC) Riga Latvia
38 P.Stradins Clinical University Hospital, Ophthalmology Clinic Riga Latvia
39 Riga East University hospital, In-patient Department "Biķernieki", Ophthalmology Clinic Riga Latvia
40 Professor K. Gibinski University Clinical Centre Katowice Poland
41 Department of Diagnostics and Microsurgery of Glaucoma Lublin Poland
42 Military Institute of Medicine Klinika Okulistyki Warsaw Poland
43 Ophthalmic Clinic Jasne Blonia Łódź Poland
44 Centro de Oftalmologia Barraquer Barcelona Spain
45 Hospital General de Catalunya Ophthalmology Department Barcelona Spain
46 Hospital QuironSalud Barcelona Barcelona Spain
47 Institut Catala de retina (ICR) Glaucoma and Investigation Department Barcelona Spain
48 Hospital General del S.A.S. de Jerez de la Frontera Cádiz Spain 11407
49 Hospital Universitario Reina Sofía de Córdoba Córdoba Spain
50 Centro de Ojos de la Coruña La Coruña Spain
51 Hospital Universitario Virgen Macarena Ophthalmology Department Sevilla Spain
52 Hospital Universitario de Torrevieja Ophthalmology Department Torrevieja Spain
53 FISABIO-Oftalmología Médica Valencia Spain
54 Ophthalmology Department Hospital Universitario Rio Hortega Valladolid Spain
55 Hospital Clinico Universitario Lozano Blesa Zaragoza Ophthalmology department Zaragoza Spain
56 Hospital Universitario Miguel Servet Ophthalmology Department Zaragoza Spain
57 City Hospitals Sunderland NHS Foundation Trust Sunderland Eye Infirmary Sunderland Tyne And Wear United Kingdom
58 NHS Grampian Aberdeen Royal Infirmary Aberdeen United Kingdom
59 Cambridge University Hospitals NHS Trust Cambridge United Kingdom
60 Ophthalmology Department, Queen Alexandra Hospital Cosham United Kingdom
61 Mid-Cheshire Hospitals NHS Foundation Trust Crewe United Kingdom
62 Northwest Anglia NHS Foundation trust Hinchingbrooke Hospital Huntingdon United Kingdom
63 Guy's & St Thomas' NHS Foundation Trust Glaucoma Research Area London United Kingdom
64 King's College Hospital London United Kingdom
65 Moorfields Eye Hospital NHS London United Kingdom
66 Western Eye Hospital London United Kingdom
67 Royal Hallamshire Hospital Sheffield United Kingdom
68 Queen Mary Hospital, King's College Hospital NHS Sidcup United Kingdom

Sponsors and Collaborators

  • Aerie Pharmaceuticals

Investigators

  • Study Director: Michelle Senchyna, Aerie Pharmaceuticals Inc.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03284853
Other Study ID Numbers:
  • PG324-CS303
First Posted:
Sep 15, 2017
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
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:

Study Results

Participant Flow

Recruitment Details Recruitment took place in 11 European countries between September 2017 and May 2020.
Pre-assignment Detail All participants underwent a period of washout for their pre-study ocular hypotensive medication for a prescribed period (up to 4 weeks or longer), depending on the medication, before receiving study medication. From the total 436 participants, 6 were not included in the analysis due to serious GCP breaches (2 from the Netarsudil/Latanoprost 0.02%/0.005% arm and 4 from the Ganfort arm). The remaining 430 participants (218 and 212 respectively) were included in the analysis.
Arm/Group Title Netarsudil/Latanoprost 0.02%/0.005% GANFORT®
Arm/Group Description PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days. Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days. GANFORT®: Topical sterile ophthalmic solution
Period Title: Overall Study
STARTED 218 212
Intent-to-Treat Population 218 212
Per-Protocol Population 169 170
Safety Population 218 212
COMPLETED 163 199
NOT COMPLETED 55 13

Baseline Characteristics

Arm/Group Title Netarsudil/Latanoprost 0.02%/0.005% GANFORT® Total
Arm/Group Description PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days. Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days. GANFORT®: Topical sterile ophthalmic solution Total of all reporting groups
Overall Participants 218 212 430
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
71
32.6%
79
37.3%
150
34.9%
>=65 years
147
67.4%
133
62.7%
280
65.1%
Age (years) [Mean (Full Range) ]
Mean
67.3
67.0
67.2
Sex: Female, Male (Count of Participants)
Female
131
60.1%
92
43.4%
223
51.9%
Male
87
39.9%
120
56.6%
207
48.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
61
28%
56
26.4%
117
27.2%
Not Hispanic or Latino
157
72%
156
73.6%
313
72.8%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
3
1.4%
3
0.7%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
4
1.8%
5
2.4%
9
2.1%
White
210
96.3%
200
94.3%
410
95.3%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
4
1.8%
4
1.9%
8
1.9%
Region of Enrollment (participants) [Number]
Austria
17
7.8%
17
8%
34
7.9%
Latvia
8
3.7%
8
3.8%
16
3.7%
Belgium
5
2.3%
5
2.4%
10
2.3%
Hungary
8
3.7%
11
5.2%
19
4.4%
Czechia
30
13.8%
31
14.6%
61
14.2%
Poland
3
1.4%
3
1.4%
6
1.4%
Italy
21
9.6%
21
9.9%
42
9.8%
United Kingdom
20
9.2%
15
7.1%
35
8.1%
France
2
0.9%
4
1.9%
6
1.4%
Germany
38
17.4%
36
17%
74
17.2%
Spain
66
30.3%
61
28.8%
127
29.5%

Outcome Measures

1. Primary Outcome
Title Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry
Description Comparison of PG324 to Ganfort for mean intraocular pressure at specified timepoints at Week 2, Week 6 and Month 3.
Time Frame Day 90

Outcome Measure Data

Analysis Population Description
A total of 430 (100%) participants were included in the Safety and Intent-to-Treat populations.
Arm/Group Title Netarsudil/Latanoprost 0.02%/0.005% GANFORT®
Arm/Group Description PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days. Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days. GANFORT®: Topical sterile ophthalmic solution
Measure Participants 218 212
Week 2
15.39
15.56
Week 6
15.64
15.25
Month 3
15.61
15.19
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Netarsudil/Latanoprost 0.02%/0.005%, GANFORT®
Comments Assuming no difference between PG324 and Ganfort, a two-tailed alpha of 0.05 (2-sided 95% CI) at each of 9 time points, a common SD of 3.5 mmHg, and a correlation between time points of ≤ 0.60, 200 ITT subjects per arm were necessary to have 85% power to show clinical non-inferiority of PG324 to Ganfort in the mean change from baseline IOP.
Type of Statistical Test Other
Comments The primary analysis was performed on the ITT population with imputation by Markov Chain Monte Carlo method.
Statistical Test of Hypothesis p-Value <0.05
Comments Linear model with IOP at the given visit and time point as the response, baseline IOP as a covariate, and treatment as a main effect factor at each time point (08:00, 10:00, and 16:00 hours at the Week 2, Week 6, and Month 3 Visits).
Method Regression, Linear
Comments Non-inferiority for PG324 was concluded if the UL of the 95% CI was ≤ l.5 mmHg at all 9 time points and ≤ l.0 mmHg at the majority of time points

Adverse Events

Time Frame Adverse events were documented for each participant from the time of signing consent until 30 days after the last dose of Investigational Product. This was a maximum period of approximately 9 months (38 weeks) for participants who completed the full study duration.
Adverse Event Reporting Description
Arm/Group Title Netarsudil/Latanoprost 0.02%/0.005% GANFORT®
Arm/Group Description PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days. Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days. GANFORT®: Topical sterile ophthalmic solution
All Cause Mortality
Netarsudil/Latanoprost 0.02%/0.005% GANFORT®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/218 (0%) 1/212 (0.5%)
Serious Adverse Events
Netarsudil/Latanoprost 0.02%/0.005% GANFORT®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 7/218 (3.2%) 7/212 (3.3%)
Cardiac disorders
Cardiac failure 0/218 (0%) 1/212 (0.5%)
Congenital, familial and genetic disorders
Dermoid cyst 0/218 (0%) 1/212 (0.5%)
Endocrine disorders
Inappropriate antidiuretic hormone secretion 1/218 (0.5%) 0/212 (0%)
Gastrointestinal disorders
Enteritis 1/218 (0.5%) 0/212 (0%)
Pancreatitis 1/218 (0.5%) 0/212 (0%)
Hepatobiliary disorders
Cholecystitis 2/218 (0.9%) 0/212 (0%)
Cholecystitis acute 1/218 (0.5%) 0/212 (0%)
Infections and infestations
Lower respiratory tract infection 0/218 (0%) 1/212 (0.5%)
Pneumonia 0/218 (0%) 1/212 (0.5%)
Injury, poisoning and procedural complications
Accidental poisoning 0/218 (0%) 1/212 (0.5%)
Road traffic accident 0/218 (0%) 1/212 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung 0/218 (0%) 1/212 (0.5%)
Transitional cell carcinoma 1/218 (0.5%) 0/212 (0%)
Nervous system disorders
Facial paralysis 0/218 (0%) 1/212 (0.5%)
Ischemic stroke 0/218 (0%) 1/212 (0.5%)
Renal and urinary disorders
Renal failure 0/218 (0%) 1/212 (0.5%)
Surgical and medical procedures
Umbilical hernia repair 1/218 (0.5%) 0/212 (0%)
Other (Not Including Serious) Adverse Events
Netarsudil/Latanoprost 0.02%/0.005% GANFORT®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 117/218 (53.7%) 53/212 (25%)
Eye disorders
Conjunctival Hyperemia 72/218 (33%) 72 23/212 (10.8%) 23
Cornea Verticillata 24/218 (11%) 24 0/212 (0%) 0
Conjunctival Hemorrhage 18/218 (8.3%) 18 5/212 (2.4%) 5
Eye Pruritus 17/218 (7.8%) 17 4/212 (1.9%) 4
Punctate Keratitis 12/218 (5.5%) 12 5/212 (2.4%) 5
Conjunctivitis Allergic 12/218 (5.5%) 12 1/212 (0.5%) 1
Infections and infestations
Viral Upper Respiratory Tract Infection 11/218 (5%) 11 10/212 (4.7%) 10
Vascular disorders
Hypertension 10/218 (4.6%) 10 17/212 (8%) 17

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 Michelle Senchyna, PhD. Vice President, Clinical Development & Medical Affairs.
Organization Aerie Pharmaceuticals Inc.
Phone +1 908 947 3551
Email msenchyna@aeriepharma.com
Responsible Party:
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03284853
Other Study ID Numbers:
  • PG324-CS303
First Posted:
Sep 15, 2017
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022