A Dose-Escalation Study Designed to Evaluate the Tolerability, Safety, Pharmacokinetics (PK), and Efficacy of Chronic Topical Ocular Application of INO-8875 in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

This study is currently recruiting participants.

Verified by Inotek Pharmaceuticals Corporation, June 2010

First Received: April 27, 2010 Last Updated: June 14, 2010 History of Changes

Sponsor:	Inotek Pharmaceuticals Corporation
Information provided by:	Inotek Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:	NCT01123785

Purpose

The purpose of this study is to evaluate how tolerable, safe, and effective it is to give INO-8875 eye drops to adults with glaucoma or ocular hypertension.

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: INO-8875 Drug: Placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase I/II Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics (Efficacy) of Chronic Twice-Daily Topical Monocular Application of INO-8875 Ophthalmic Formulation in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

U.S. FDA Resources

Further study details as provided by Inotek Pharmaceuticals Corporation:

Primary Outcome Measures:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of Participants with decreased Intra-ocular pressure [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	110
Study Start Date:	May 2010
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: Placebo Comparator Matched vehicle-control	Drug: Placebo Matched vehicle-control
INO-8875: Experimental Adenosine agonist eye drop	Drug: INO-8875 eye drops for 14 days in one eye

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG).
Aged 18 to 75 years.
Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion Criteria:

No significant visual field loss or any new field loss within the past year.
Cup-to-disc ratio ≥0.8
Central corneal thickness <500 µm or >600 µm
History of adult asthma or chronic obstructive pulmonary disease
A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123785

Contacts

Contact: Tiffany Crowell

781-676-2100 ext 2109

tcrowell@inotekcorp.com

Locations

United States, California
Lugene Eye Institute	Recruiting
Glendale, California, United States, 91205
Contact: Sherif M El-Harazi, MD elharazi@lugeneeye.com
Contact: Attiq Chaudhry, CCRC achaudhry@lugeneeye.com
Macy Eye Center	Recruiting
Los Angeles, California, United States
Contact: Jonathan I Macy, MD jimacy@macyeyecenter.com
Contact: Chantelle Dass chantelle@macyeyecenter.com
Principal Investigator: Jonathan I Macy, MD
United States, Kansas
Stiles Eye Care Excellence	Recruiting
Overland Park, Kansas, United States
Contact: Dr. Brett King, OD 913-897-9299 bking@stileseye.com
Contact: Rachel A Roy 913-897-9299 rroy@stileseye.com
Principal Investigator: Michael C Stiles, MD
United States, Kentucky
Taustine Eye Center	Recruiting
Louisville, Kentucky, United States
Contact: Bridget M Adkins, BS 502-458-0728 ext 5 eyesearch@hotmail.com
Contact: Ashley B Griffith, BS 502-458-0728 ext 5 eyesearch@hotmail.com
Principal Investigator: Robert Williams, MD
United States, New York
New York Eye and Ear Infirmary	Not yet recruiting
New York, New York, United States
Contact: Paul A Sidoti, MD 212-979-4251 psidoti@nyee.edu
Contact: Katy Tai 212-979-4251 ktai@nyee.edu
Principal Investigator: Paul A Sidoti, MD
United States, North Carolina
Cornerstone Eye Care	Recruiting
High Point, North Carolina, United States, 27262
Contact: Cheryl L Hill 336-802-2255 cheryl.hill@cornerstonehealthcare.com
Principal Investigator: Michael E Tepedino

Sponsors and Collaborators

Inotek Pharmaceuticals Corporation

More Information

No publications provided

Responsible Party:	Inotek ( Rudolf Baumgartner, MD )
ClinicalTrials.gov Identifier:	NCT01123785 History of Changes
Other Study ID Numbers:	IPC-10-2009
Study First Received:	April 27, 2010
Last Updated:	June 14, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Inotek Pharmaceuticals Corporation:

glaucoma
ocular hypertension
adenosine agonist
eye drop
primary open angle glaucoma

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 07, 2010