Overview

This trial has been completed.

Conditions primary open-angle glaucoma (poag), ocular hypertension (oht)
Treatments trabodenoson 4.5% bid, trabodenoson 6.0% qd, trabodenoson 3.0% qd, timolol 0.5% bid, placebo bid
Phase phase 3
Sponsor Inotek Pharmaceuticals Corporation
Start date September 2015
End date November 2016
Trial size 303 participants
Trial identifier NCT02565173, IPC-01-2015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
trabodenoson 4.5% Ophthalmic Formulation
trabodenoson 4.5% bid INO-8875
Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.
(Experimental)
trabodenoson 6.0% Ophthalmic Formulation
trabodenoson 6.0% qd INO-8875
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.
(Experimental)
trabodenoson 3.0% Ophthalmic Formulation
trabodenoson 3.0% qd INO-8875
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.
(Active Comparator)
timolol 0.5% Ophthalmic Formulation
timolol 0.5% bid Timoptic
Timolol 0.5% administered twice per day in both eyes for 12 weeks.
(Placebo Comparator)
placebo Ophthalmic Formulation
placebo bid
Placebo administered twice per day in both eyes for 12 weeks.

Primary Outcomes

Measure
Mean Intraocular Pressure (IOP)
time frame: Three Months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Inotek Pharmaceuticals Corporation.