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

Phase 2

Completed

• Conditions: Primary Open-Angle Glaucoma (POAG); Ocular Hypertension (OHT)
• Interventions: Drug: Trabodenoson; Drug: Latanoprost; Drug: Timolol

• Registration Number: NCT01917383
• Lead Sponsor: Inotek Pharmaceuticals Corporation

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).

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-06
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Disposition First Submitted: 2015-03-23
• Disposition First Submitted QC: 2015-04-11
• Disposition First Posted: 2015-05-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trabodenoson Plus Latanoprost	Trabodenoson	Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
Timolol Plus Latanoprost	Latanoprost	A Beta-blocker eye drop plus a prostaglandin analogue eye drop
Timolol Plus Latanoprost	Timolol	A Beta-blocker eye drop plus a prostaglandin analogue eye drop
Trabodenoson Plus Latanoprost	Latanoprost	Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	12 weeks

Trial Locations

Locations (1)

Chiltern; 🇺🇸 Bristol, Tennessee, United States