NCT01789736

Brief Summary

In the double-masked, randomized, multi-center, active-controlled parallel study, patients will be randomized to receive either a fixed dose combination of AR-12286 and travoprost, AR-12286, or travoprost. The hypothesis is that there is no difference between each treatment arm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 17, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

February 9, 2013

Last Update Submit

February 17, 2014

Conditions

Open Angle GlaucomaOcular Hypertension

Keywords

GlaucomaOcular hypertensionAR-12286Travoprost

Outcome Measures

Primary Outcomes (1)

  • Mean diurnal IOP

    The primary efficacy endpoint will be the mean diurnal IOP across subjects within treatment group and time point at Day 28.

    28 Days

Secondary Outcomes (1)

  • IOP

    7-28 days

Study Arms (3)

PG286

EXPERIMENTAL

PG286 Ophthalmic Solution q.d. O.U.

Drug: PG286 Ophthalmic Solution 0.5%

AR-12286 Ophthalmic Solution 0.5%

EXPERIMENTAL

AR-12286 Ophthalmic Solution 0.5% q.d. O.U.

Drug: AR-12286 Ophthalmic Solution 0.5%

Travoprost 0.004%

ACTIVE COMPARATOR

Travoprost 0.004% q.d. O.U.

Drug: Travoprost Ophthalmic Solution 0.004%

Interventions

PG286 Ophthalmic Solution 0.5%DRUG

PG286 Ophthalmic Solution

PG286
AR-12286 Ophthalmic Solution 0.5%DRUG

AR-12286 Ophthalmic Solution 0.5%

AR-12286 Ophthalmic Solution 0.5%
Travoprost Ophthalmic Solution 0.004%DRUG

Travoprost Ophthalmic Solution 0.004%

Travoprost 0.004%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or greater.
  • Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
  • Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP \>21 mmHg at 10:00 and 16:00 hrs.
  • 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.

You may not qualify if:

  • Excluded from the study will be individuals with the following characteristics:
  • Ophthalmic (in either eye):
  • Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
  • Intraocular pressure \> 35 mm Hg, or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
  • Known hypersensitivity to any component of the formulation (benzalkonium chloride, zinc, etc.), travoprost, or to topical anesthetics.
  • Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
  • Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
  • 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, inflammation, clinically significant blepharitis, conjunctivitis, or a history of herpes simplex keratitis at screening.
  • Ocular medication 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).
  • Clinically significant ocular disease (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).
  • Central corneal thickness greater than 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Kenneth Sall, M.D.

Artesia, California, 90701, United States

Location

United Medical Research Institute

Inglewood, California, 90301, United States

Location

Aesthetic Eye Care Institute

Newport Beach, California, 92657, United States

Location

Bacharach practice

Petaluma, California, 94954, United States

Location

Centre For Health Care

Poway, California, 92064, United States

Location

Clayton Eye Center

Morrow, Georgia, 30260, United States

Location

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

Location

Bradley Kwapiszeski, MD

Shawnee Mission, Kansas, 66204, United States

Location

Taustine Eye Center

Louisville, Kentucky, 40217, United States

Location

Alan L Robin, M.D.

Baltimore, Maryland, 21209, United States

Location

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, 21078, United States

Location

Great Lakes Eye Care

Saint Joseph, Michigan, 49085, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

Rochester Ophthalmological Group

Rochester, New York, 14618, United States

Location

Jeffrey Schultz, M.D.

The Bronx, New York, 10467, United States

Location

Charlotte Eye Ear Nose & Throat Associates, P.A.

Belmont, North Carolina, 28012, United States

Location

The Eye Institute

Tulsa, Oklahoma, 74104, United States

Location

Texan Eye

Austin, Texas, 78731, United States

Location

Medical Center Ophth. Associates

San Antonio, Texas, 78731, United States

Location

Stacy R. Smith, M.D.

Salt Lake City, Utah, 84117, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2013

First Posted

February 12, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 17, 2014

Record last verified: 2014-02

Locations

US(21)