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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2014

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

Interventions

  • Drug: Trabodenoson
    • Ophthalmic eye drop
  • Drug: Latanoprost
    • Ophthalmic eye drop
  • Drug: Timolol
    • Ophthalmic eye drop

Arms, Groups and Cohorts

  • Experimental: Trabodenoson Plus Latanoprost
    • Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
  • Active Comparator: Timolol Plus Latanoprost
    • A Beta-blocker eye drop plus a prostaglandin analogue eye drop

Clinical Trial Outcome Measures

Primary Measures

  • Intraocular Pressure (IOP)
    • Time Frame: 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Inotek Pharmaceuticals Corporation
  • Provider of Information About this Clinical Study
    • Sponsor

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