AR-12286 in Combination With Latanoprost

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01302249
First received: February 18, 2011
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular pressure (IOP).


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Topical
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-masked, Randomized, Active-controlled, Crossover Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 or Timolol Added to Patients With Elevated Intraocular Pressure Currently Using Latanoprost

Resource links provided by NLM:


Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will be the mean IOP across subjects within treatment group at each study visit at each post-treatment timepoint.


Secondary Outcome Measures:
  • Ocular safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject symptom queries.

  • Systemic safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Heart rate, and blood pressure.


Enrollment: 66
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AR-12286
AR-12286 Ophthalmic Solution 0.5%
Drug: Topical
Ophthalmic Solution
Active Comparator: Timolol
Timolol maleate ophthalmic solution 0.5%
Drug: Topical
Ophthalmic Solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or greater.
  • Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
  • Currently using prostaglandin analogue (monotherapy or combination therapy) O.U. ≥ 1 month at time of study entry (first qualification visit) in study eye(s).
  • Qualification Visit 1 (Screening) IOP at 16:00 hrs: PG monotherapy patients: ≥ 18 mm Hg; Combination therapy patients: >= 16 mm Hg. Qualification Visit 2 (post latanoprost run-in) IOP ≥ 20 mm Hg at 08:00 hrs and 10:00 hrs, IOP ≥ 18 mm Hg at 16:00 hrs in study eye(s). (Note: combination therapy may include any combination of topical ocular hypotensive agents).
  • Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
  • Able and willing to give signed informed consent and follow study instructions

Exclusion Criteria:

In either eye:

  • Previously randomized to treatment in a clinical study of AR-12286.
  • Intraocular pressure > 36 mm Hg.
  • History of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy
  • Known hypersensitivity or contraindication to timolol maleate ophthalmic solution, or any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics, including history of conjunctival hyperemia with topical latanoprost of severity greater than 1 on a 0-3 scale.
  • Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
  • Contact lens wear within 30 minutes of instillation of study medication.
  • PG monotherapy patients: Ocular hypotensive medication (other than prostaglandin) within 4 weeks of Visit 0 (Study entry, first qualification visit). Combination therapy patients: Ocular hypotensive medication (other than prostaglandin and current additional agent) within 4 weeks of Visit 0 (Study entry, first qualification visit).
  • Conjunctival hyperemia of grade 2+ or greater at Visit 1.
  • Any other ocular medication within 4 weeks of Visit 1 with the exception of lubricating drops for dry eye (which may be used throughout the study).
  • Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that treatment with only latanoprost for two periods of up to 4 weeks is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field loss).
  • Any abnormality preventing reliable applanation tonometry of either eye.

In study eye(s):

  • Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
  • Previous glaucoma intraocular surgery or laser procedures.
  • Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  • Central corneal thickness greater than 600 µ.

Systemic:

  • Known bronchial asthma (history or current), severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block or overt cardiac failure.
  • Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood.
  • Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
  • Participation in any investigational study within the past 30 days.
  • Changes of systemic medication that could have a substantial effect on IOP 4 weeks prior to screening, or anticipated during the study.
  • Due to status of preclinical safety program, 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302249

Locations
United States, Connecticut
David Silverstone, M.D.
New Haven, Connecticut, United States, 06510
United States, Georgia
Coastal Research Associates, LLC
Roswell, Georgia, United States, 30076
United States, Kansas
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Taustine Eye Center
Louisville, Kentucky, United States, 40217
United States, Maryland
Alan L Robin, M.D.
Baltimore, Maryland, United States, 21209
United States, Missouri
Comprehensive Eye Care
St Louis, Missouri, United States, 63090
United States, New York
Rochester Ophthalmology Group
Rochester, New York, United States, 14618
Glaucoma Consultants of the Capital Region
Slingerlands, New York, United States, 12159
United States, North Carolina
Charlotte Eye Ear Nose and Throat
Charlotte, North Carolina, United States, 28210
Thomas K. Mundorf, M.D.
Charlotte, North Carolina, United States, 28204
United States, Oklahoma
The Eye Institute
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Texas
Cataract & Glaucoma Center
El Paso, Texas, United States, 79902
United States, Utah
Stacy R. Smith, M.D.
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Aerie Pharmaceuticals
  More Information

No publications provided

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01302249     History of Changes
Other Study ID Numbers: AR-12286-CS203
Study First Received: February 18, 2011
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Glaucoma
Intraocular pressure
Ocular hypertension

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on April 16, 2014