Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

NCT02565173 | Completed Phase 3

• 1 other identifier: IPC-01-2015
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma. All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled. The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks. Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.

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)

• Mean Intraocular Pressure (IOP)

  Three Months

Other Outcomes (1)

• Safety Parameters, including treatment emergent adverse events, to assess tolerability and safety.

  Through Study Completion, up to 13 weeks.

Study Arms (5)

trabodenoson 4.5% BID

EXPERIMENTAL

trabodenoson 4.5% Ophthalmic Formulation

Drug: trabodenoson 4.5% BID

trabodenoson 6.0% QD

EXPERIMENTAL

trabodenoson 6.0% Ophthalmic Formulation

Drug: trabodenoson 6.0% QD

trabodenoson 3.0% QD

EXPERIMENTAL

trabodenoson 3.0% Ophthalmic Formulation

Drug: trabodenoson 3.0% QD

timolol 0.5% BID

ACTIVE COMPARATOR

timolol 0.5% Ophthalmic Formulation

Drug: timolol 0.5% BID

placebo BID

PLACEBO COMPARATOR

placebo Ophthalmic Formulation

Drug: placebo BID

Interventions

trabodenoson 4.5% BID DRUG

Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.

Also known as: INO-8875

trabodenoson 4.5% BID

trabodenoson 6.0% QD DRUG

Trabodenoson 6.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.

Also known as: INO-8875

trabodenoson 6.0% QD

trabodenoson 3.0% QD DRUG

Trabodenoson 3.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.

Also known as: INO-8875

trabodenoson 3.0% QD

timolol 0.5% BID DRUG

Timolol 0.5% administered twice per day in both eyes for 12 weeks.

Also known as: Timoptic

timolol 0.5% BID

placebo BID DRUG

Placebo administered twice per day in both eyes for 12 weeks.

placebo BID

Eligibility Criteria

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

You may qualify if:

• Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
• Mean Intraocular pressure (IOP) of ≥24 and ≤34

You may not qualify if:

• Significant visual field loss or any new field loss within the past year
• Cup-to-disc ratio \>0.8
• Central corneal thickness \<490 µm or \>610 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)

Inotek Pharmaceuticals Corporation

Lexington, Massachusetts, 02421, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

trabodenoson; BID protein, human; INO-8875; Timolol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Cadmus C Rich, MD,MBA,CPE

  Inotek Pharmaceuticals Corp.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 28, 2015
• First Posted: October 1, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (1)