AR-12286 in Combination With Latanoprost

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302249
• Other study ID #: AR-12286-CS203
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2011
• Last updated: April 18, 2014
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2014
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

• Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Latanoprost 0.005%
q.d.
• AR-12286 Ophthalmic Solution 0.5%

• Timolol maleate ophthalmic solution 0.5%

Locations

Country	Name	City	State
United States	Alan L Robin, M.D.	Baltimore	Maryland
United States	Charlotte Eye Ear Nose and Throat	Charlotte	North Carolina
United States	Thomas K. Mundorf, M.D.	Charlotte	North Carolina
United States	Cataract & Glaucoma Center	El Paso	Texas
United States	Taustine Eye Center	Louisville	Kentucky
United States	David Silverstone, M.D.	New Haven	Connecticut
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Rochester Ophthalmology Group	Rochester	New York
United States	Coastal Research Associates, LLC	Roswell	Georgia
United States	Stacy R. Smith, M.D.	Salt Lake City	Utah
United States	Heart of America Eye Care, P.A.	Shawnee Mission	Kansas
United States	Glaucoma Consultants of the Capital Region	Slingerlands	New York
United States	Comprehensive Eye Care	St Louis	Missouri
United States	The Eye Institute	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	The primary efficacy endpoint will be the mean IOP across subjects within treatment group at each study visit at each post-treatment timepoint.	28 days	No
Secondary	Ocular safety	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.	28 days	Yes
Secondary	Systemic safety	Heart rate, and blood pressure.	28 days	Yes