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Completed

NCT Number: NCT01917383

A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost 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).

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Key information

Conditions

Primary Open-Angle Glaucoma (POAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension Ocular Hypertension (OHT)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chiltern

Bristol, Tennessee, 37620, United States

About this study

Criteria

Inclusion criteria

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Trabodenoson

Drug

Ophthalmic eye drop

Other names: INO-8875

latanoprost

Drug

Ophthalmic eye drop

Other names: Xalatan

Timolol

Drug

Ophthalmic eye drop

Other names: Timoptic

Primary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Inotek Pharmaceuticals Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 6, 2013
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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