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

Sponsor

Inotek Pharmaceuticals Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01917383

Collaborator

(none)

101

Enrollment

Location

Arms

Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Primary Open-Angle Glaucoma (POAG) Ocular Hypertension (OHT)	Drug: Trabodenoson Drug: Latanoprost Drug: Timolol	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Intraocular Pressure (IOP) [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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