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 has been completed.

Sponsor:

Information provided by (Responsible Party):

Inotek Pharmaceuticals Corporation

ClinicalTrials.gov Identifier:

NCT01123785

First received: April 27, 2010

Last updated: October 11, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 27, 2010
Last Updated Date	October 11, 2012
Start Date ^ICMJE	May 2010
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 12, 2010)	Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01123785 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 12, 2010)	Number of Participants with decreased Intra-ocular pressure [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Glaucoma Ocular Hypertension
Intervention ^ICMJE	Drug: INO-8875 eye drops for 14 days in one eye Drug: Placebo Matched vehicle-control
Study Arm (s)	Placebo Comparator: Control Matched vehicle-control Intervention: Drug: Placebo Experimental: INO-8875 Adenosine agonist eye drop Intervention: Drug: INO-8875
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	144
Completion Date	January 2012
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 77 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01123785
Other Study ID Numbers ^ICMJE	IPC-10-2009
Has Data Monitoring Committee	No
Responsible Party	Inotek Pharmaceuticals Corporation
Study Sponsor ^ICMJE	Inotek Pharmaceuticals Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Inotek Pharmaceuticals Corporation
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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