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

NCT01917383 | Completed Phase 2

• 1 other identifier: IPC-01-2013
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Open-Angle Glaucoma (POAG); Ocular Hypertension (OHT)

Keywords

glaucoma; primary open angle glaucoma; ocular hypertension; adenosine agonist; eye drop; trabodenoson; trabecular meshwork

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

  12 weeks

Study Arms (2)

Trabodenoson Plus Latanoprost

EXPERIMENTAL

Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop

Drug: Trabodenoson; Drug: Latanoprost

Timolol Plus Latanoprost

ACTIVE COMPARATOR

A Beta-blocker eye drop plus a prostaglandin analogue eye drop

Drug: Latanoprost; Drug: Timolol

Interventions

Trabodenoson DRUG

Ophthalmic eye drop

Also known as: INO-8875

Trabodenoson Plus Latanoprost

Latanoprost DRUG

Ophthalmic eye drop

Also known as: Xalatan

Timolol Plus Latanoprost; Trabodenoson Plus Latanoprost

Timolol DRUG

Ophthalmic eye drop

Also known as: Timoptic

Timolol Plus Latanoprost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Inotek Pharmaceuticals Corporation: lead

Study Sites (1)

Chiltern

Bristol, Tennessee, 37620, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

trabodenoson; INO-8875; Latanoprost; Timolol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 6, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

US (1)