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

Ocular Hypertension (OHT) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917383
• Other study ID #: IPC-01-2013
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2013
• Last updated: November 28, 2017
• Start date: August 2013
• Est. completion date: September 2014

Study information

• Verified date: November 2017
• Source: Inotek Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Chiltern	Bristol	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Inotek Pharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)		12 weeks