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

Phase 3

Completed

• Conditions: Primary Open-Angle Glaucoma (POAG); Ocular Hypertension (OHT)
• Interventions: Drug: trabodenoson 6.0% QD; Drug: timolol 0.5% BID; Drug: placebo BID; Drug: trabodenoson 4.5% BID; Drug: trabodenoson 3.0% QD

• Registration Number: NCT02565173
• Lead Sponsor: Inotek Pharmaceuticals Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trabodenoson 6.0% QD	trabodenoson 6.0% QD	trabodenoson 6.0% Ophthalmic Formulation
timolol 0.5% BID	timolol 0.5% BID	timolol 0.5% Ophthalmic Formulation
placebo BID	placebo BID	placebo Ophthalmic Formulation
trabodenoson 4.5% BID	trabodenoson 4.5% BID	trabodenoson 4.5% Ophthalmic Formulation
trabodenoson 3.0% QD	trabodenoson 3.0% QD	trabodenoson 3.0% Ophthalmic Formulation

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP)	Three Months

Trial Locations

Locations (1)

Inotek Pharmaceuticals Corporation; 🇺🇸 Lexington, Massachusetts, United States