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

NCT02565173 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2016-12-06

No results posted yet for this study

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)

Interventions

DRUG

trabodenoson 4.5% BID

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

DRUG

trabodenoson 6.0% QD

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.

DRUG

trabodenoson 3.0% QD

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.

DRUG

timolol 0.5% BID

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

DRUG

placebo BID

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

Sponsors & Collaborators

  • Inotek Pharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Cadmus C Rich, MD,MBA,CPE · Inotek Pharmaceuticals Corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02565173 on ClinicalTrials.gov