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
  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 1
Phase 2

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:


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 ]

Enrollment: 144
Study Start Date: May 2010
Study Completion Date: January 2012
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 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Locations
United States, California
Lugene Eye Institute
Glendale, California, United States, 91205
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: October 11, 2012
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 April 17, 2014