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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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
INO-8875
Placebo
Sponsored by
Inotek Pharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, ocular hypertension, adenosine agonist, eye drop, primary open angle glaucoma

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lugene Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

INO-8875

Arm Description

Matched vehicle-control

Adenosine agonist eye drop

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary Outcome Measures

Number of Participants with decreased Intra-ocular pressure

Full Information

First Posted
April 27, 2010
Last Updated
October 11, 2012
Sponsor
Inotek Pharmaceuticals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01123785
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inotek Pharmaceuticals Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
glaucoma, ocular hypertension, adenosine agonist, eye drop, primary open angle glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Matched vehicle-control
Arm Title
INO-8875
Arm Type
Experimental
Arm Description
Adenosine agonist eye drop
Intervention Type
Drug
Intervention Name(s)
INO-8875
Intervention Description
eye drops for 14 days in one eye
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched vehicle-control
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Number of Participants with decreased Intra-ocular pressure
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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