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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01123785
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : October 15, 2012
Information provided by (Responsible Party):
Inotek Pharmaceuticals Corporation

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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: INO-8875 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Number of Participants with decreased Intra-ocular pressure [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01123785

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United States, California
Lugene Eye Institute
Glendale, California, United States, 91205
Sponsors and Collaborators
Inotek Pharmaceuticals Corporation
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Responsible Party: Inotek Pharmaceuticals Corporation Identifier: NCT01123785    
Other Study ID Numbers: IPC-10-2009
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012
Keywords provided by Inotek Pharmaceuticals Corporation:
ocular hypertension
adenosine agonist
eye drop
primary open angle glaucoma
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases