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

Ocular Hypertension (OHT) Clinical Trial

— MATrX-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565173
• Other study ID #: IPC-01-2015
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2015
• Last updated: December 2, 2016
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Inotek Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Ocular Hypertension (OHT)
• Primary Open-Angle Glaucoma (POAG)

Intervention

Drug:
• trabodenoson 4.5% BID
Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.
• 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.
• 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.
• timolol 0.5% BID
Timolol 0.5% administered twice per day in both eyes for 12 weeks.
• placebo BID
Placebo administered twice per day in both eyes for 12 weeks.

Locations

Country	Name	City	State
United States	Inotek Pharmaceuticals Corporation	Lexington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Inotek Pharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Parameters, including treatment emergent adverse events, to assess tolerability and safety.		Through Study Completion, up to 13 weeks.	No
Primary	Mean Intraocular Pressure (IOP)		Three Months	No