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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

NCT ID: NCT01123785

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-01-31

Brief Summary

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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

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Conditions

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Glaucoma Ocular Hypertension

Keywords

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glaucoma ocular hypertension adenosine agonist eye drop primary open angle glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Matched vehicle-control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched vehicle-control

INO-8875

Adenosine agonist eye drop

Group Type EXPERIMENTAL

INO-8875

Intervention Type DRUG

eye drops for 14 days in one eye

Interventions

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INO-8875

eye drops for 14 days in one eye

Intervention Type DRUG

Placebo

Matched vehicle-control

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inotek Pharmaceuticals Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lugene Eye Institute

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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IPC-10-2009

Identifier Type: -

Identifier Source: org_study_id