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Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

NCT ID: NCT02565173

Last Updated: 2016-12-06

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

PHASE3

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-11-30

Brief Summary

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Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma.

All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled.

The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks.

Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.

Detailed Description

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Conditions

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Primary Open-Angle Glaucoma (POAG) Ocular Hypertension (OHT)

Keywords

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glaucoma primary open-angle glaucoma ocular hypertension adenosine agonist eye drop trabodenoson trabecular meshwork

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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trabodenoson 4.5% BID

trabodenoson 4.5% Ophthalmic Formulation

Group Type EXPERIMENTAL

trabodenoson 4.5% BID

Intervention Type DRUG

Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.

trabodenoson 6.0% QD

trabodenoson 6.0% Ophthalmic Formulation

Group Type EXPERIMENTAL

trabodenoson 6.0% QD

Intervention Type DRUG

Trabodenoson 6.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.

trabodenoson 3.0% QD

trabodenoson 3.0% Ophthalmic Formulation

Group Type EXPERIMENTAL

trabodenoson 3.0% QD

Intervention Type DRUG

Trabodenoson 3.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.

timolol 0.5% BID

timolol 0.5% Ophthalmic Formulation

Group Type ACTIVE_COMPARATOR

timolol 0.5% BID

Intervention Type DRUG

Timolol 0.5% administered twice per day in both eyes for 12 weeks.

placebo BID

placebo Ophthalmic Formulation

Group Type PLACEBO_COMPARATOR

placebo BID

Intervention Type DRUG

Placebo administered twice per day in both eyes for 12 weeks.

Interventions

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trabodenoson 4.5% BID

Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.

Intervention Type DRUG

trabodenoson 6.0% QD

Trabodenoson 6.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.

Intervention Type DRUG

trabodenoson 3.0% QD

Trabodenoson 3.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.

Intervention Type DRUG

timolol 0.5% BID

Timolol 0.5% administered twice per day in both eyes for 12 weeks.

Intervention Type DRUG

placebo BID

Placebo administered twice per day in both eyes for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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INO-8875 INO-8875 INO-8875 Timoptic

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
* Mean Intraocular pressure (IOP) of ≥24 and ≤34

Exclusion Criteria

* Significant visual field loss or any new field loss within the past year
* Cup-to-disc ratio \>0.8
* Central corneal thickness \<490 µm or \>610 µm
* A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
Minimum Eligible Age

18 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

Principal Investigators

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Cadmus C Rich, MD,MBA,CPE

Role: STUDY_DIRECTOR

Inotek Pharmaceuticals Corp.

Locations

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Inotek Pharmaceuticals Corporation

Lexington, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IPC-01-2015

Identifier Type: -

Identifier Source: org_study_id