A Double-masked Study of AR-13324 in Patients With Glaucoma and Ocular Hypertension
Information source: Aerie Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ocular Hypertension; Open-angle Glaucoma
Intervention: AR-13324 Ophthalmic Solution, 0.02% (Drug); Timolol maleate Ophthalmic Solution, 0.5% (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Aerie Pharmaceuticals Official(s) and/or principal investigator(s):
Theresa Heah, MD, Study Director, Affiliation: Aerie Pharmaceuticals, Inc.
Summary
To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324
Ophthalmic Solution, 0. 02% compared to the active comparator Timolol Maleate Ophthalmic
Solution 0. 5%
Clinical Details
Official title: A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution, 0.02% q.d. and b.i.d. Compared to Timolol Maleate Ophthalmic Solution, 0.5% b.i.d. in Patients With Elevated Intraocular Pressure
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: IOP
Secondary outcome: Ocular safety
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Subject inclusion criteria
1. 0-2 years of age and 18 years or greater.
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
3. Unmedicated (post-washout) IOP >20 mm Hg and < 27 mm Hg in the study eye at 2
qualification visits (08: 00 hr), 2-7 days apart. At second qualification visit, IOP
> 17 mm Hg and < 27 mm Hg at 10: 00 and 16: 00 hrs (in the same eye).
4. Corrected visual acuity in each eye +1. 0 logMAR or better by ETDRS in each eye
(equivalent to 20/200).
5. Able and willing to give signed informed consent (parent or guardian consent for
pediatric patient) and follow study instructions.
Subject exclusion criteria
Ophthalmic:
1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle
closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT
acceptable.
2. Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes (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 combinations count as two medications.
3. Known hypersensitivity to any component of the formulations to be used (benzalkonium
chloride, etc.), to topical anesthetics or beta-adrenoceptor antagonists.
4. Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye
5. Refractive surgery in either eye (e. g., radial keratotomy, PRK, LASIK, corneal
cross-linking, etc.).
6. Ocular trauma in either eye within the six months prior to screening, or ocular
surgery or non-refractive laser treatment within the three months prior to screening.
7. Recent or current evidence of ocular infection or inflammation in either eye.
Current evidence of clinically significant blepharitis, conjunctivitis, or a history
of herpes simplex or zoster keratitis at screening in either eye.
8. Ocular medication in either eye of any kind within 30 days of screening, with the
exception of a) ocular hypotensive medications (which must be washed out according to
the provided schedule), b) lid scrubs (which may be used prior to, but not after
screening) or c) lubricating drops for dry eye (which may be used throughout the
study).
9. Clinically significant ocular disease in either eye (e. g., corneal edema, uveitis,
severe keratoconjunctivitis sicca) which might interfere with the study, including
glaucomatous damage so severe that washout of ocular hypotensive medications for one
month is not judged safe (e. g., cup-disc ratio > 0. 8, severe visual field defect).
10. Central corneal thickness in either eye greater than 600 µm at screening.
11. Any abnormality in either eye preventing reliable applanation tonometry of either
eye.
Systemic:
12. Clinically relevant abnormalities (as determined by the investigator) in laboratory
tests at screening which may impact the study.
13. Known hypersensitivity or contraindication to beta-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; severe diabetes).
14. Clinically significant systemic disease (e. g., uncontrolled diabetes, myasthenia
gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere
with the study.
15. Participation in any investigational study within 30 days prior to screening.
16. Changes of systemic medication that could have an effect on IOP within 30 days prior
to screening, or anticipated during the study.
17. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or
not using a medically acceptable form of birth control. An adult woman is considered
to be of childbearing potential unless she is one year post-menopausal or three
months post-surgical sterilization. All females of childbearing potential must have a
negative urine pregnancy test result at the screening examination and must not intend
to become pregnant during the study..
Locations and Contacts
Aerie Pharmaceuticals, Bedminster, New Jersey 07921, United States
Additional Information
Starting date: July 2014
Last updated: July 9, 2015
|
