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 August 2011 by Inotek Pharmaceuticals Corporation

First Received on April 27, 2010. Last Updated on August 30, 2011 History of Changes

Sponsor:	Inotek Pharmaceuticals Corporation
Information provided by (Responsible Party):	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 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

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride

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:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Control Matched vehicle-control	Drug: Placebo Matched vehicle-control
Experimental: INO-8875 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: Laura Blackburn

508-878-0658

blackburnla@me.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

Sponsors and Collaborators

Inotek Pharmaceuticals Corporation

More Information

No publications provided

Responsible Party:	Inotek Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:	NCT01123785 History of Changes
Other Study ID Numbers:	IPC-10-2009
Study First Received:	April 27, 2010
Last Updated:	August 30, 2011
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 February 02, 2012