A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

November 28, 2017 updated by: Inotek Pharmaceuticals Corporation

A Phase II Multi-center, Randomized Study to Evaluate the Monocular Addition of Trabodenoson (INO-8875) Ophthalmic Formulation to Latanoprost Ophthalmic Solution Therapy in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and the safety and tolerability profile of trabodenoson ophthalmic formulation compared to timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic solution 0.005% once every evening (QPM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Criteria

Inclusion Criteria:

  1. Subject has signed and dated the current informed consent form (ICF).
  2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
  3. Aged 18 or older.
  4. 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. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • CHILTERN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject has signed and dated the current informed consent form (ICF).
  2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
  3. Aged 18 or older.
  4. 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. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Trabodenoson Plus Latanoprost
Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
Drug: Trabodenoson
Ophthalmic eye drop
Other Names:
  • INO-8875
Drug: Latanoprost
Ophthalmic eye drop
Other Names:
  • Xalatan
ACTIVE_COMPARATOR: Timolol Plus Latanoprost
A Beta-blocker eye drop plus a prostaglandin analogue eye drop
Drug: Latanoprost
Ophthalmic eye drop
Other Names:
  • Xalatan
Drug: Timolol
Ophthalmic eye drop
Other Names:
  • Timoptic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular Pressure (IOP)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inotek Pharmaceuticals Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

August 5, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (ESTIMATE)

August 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPC-01-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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