Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG

Phase II, Randomized, Double-masked, Active-controlled Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Subjects With Ocular Hypertension or Primary Open-Angle Glaucoma

Phase II, randomized, double-masked study to evaluate the efficacy and tolerability of topical ocular delivery of fixed-dosed combinations of trabodenoson and latanoprost in 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 (if washout is needed), including their routine glaucoma medications. During the Placebo Run-In Period, placebo is applied twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing in a masked manner. AM vs PM dosing is masked utilizing Placebo in addition to the active drug product. During the Treatment Period, study drug (Active and Placebo) eye drop applications will occur twice daily, in the morning and in the evening. The Treatment Period will be 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 overall benefit/risk profile of binocular topical application of different doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost (0.005% or 0.0025%) one drop daily (QD) for 8 weeks.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension (OHT); Primary Open-Angle Glaucoma (POAG)
• Intervention / Treatment: Drug: trabodenoson 6.0% / latanoprost 0.005% QD; Drug: trabodenoson 3.0% / latanoprost 0.005% QD; Drug: trabodenoson 6.0% / latanoprost 0.0025% QD; Drug: latanoprost 0.005% QD; Drug: latanoprost 0.0025% QD

Detailed Description

This is a phase II, randomized, double-masked study to evaluate the efficacy and tolerability of topical ocular delivery of fixed-dose combinations of trabodenoson and latanoprost in subjects with OHT or POAG.

The Primary Objective of this Trial is to evaluate the efficacy of different topical ocular doses of trabodenoson (3.0% and 6.0%) when added to latanoprost (0.005% or 0.0025%), one drop daily to both eyes over two consecutive 4 week periods. The Secondary Objective is to evaluate the tolerability and safety of different doses of trabodenoson (3.0% and 6.0%) when added to latanoprost (0.005% or 0.0025%), one drop daily to both eyes over two consecutive 4 week periods. the Hypotheses is that topical ocular co-administration of 3.0% or 6.0% trabodenoson plus latanoprost 0.0025% or 0.005% ophthalmic formulation will reduce IOP and be well-tolerated.

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 (vehicle control matched to trabodenoson) is applied twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing in a manner that is masked to the patient. The Treatment Period will be followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled.

To mimic what is generally seen in clinical trials, the number of subjects with ocular hypertension as their diagnosis will be limited to approximately 30% of the total subjects enrolled. Additionally, so the trial mirrors the general population demographics (so as to improve generalizability of the results) the proportion of African American subjects will be approximately 25% or less but not less than 12% of the total subjects enrolled.

The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of different doses of trabodenoson (3.0% and 6.0%) when added to latanoprost (0.005% or 0.0025%) one drop daily over two consecutive 4 week periods in subjects with POAG or OHT. Data collection will include efficacy (masked-IOPs), local (ophthalmic) and systemic tolerability and safety assessments

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Lexington, Massachusetts, United States, 02421
      • Inotek Pharmaceuticals Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
• Mean Intraocular pressure (IOP) of ≥25 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: trabodenoson 6.0% /latanoprost 0.005% QD; trabodenoson 6.0% / latanoprost 0.005% QD FDC	Drug: trabodenoson 6.0% / latanoprost 0.005% QD; Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
EXPERIMENTAL: trabodenoson 3.0% /latanoprost 0.005% QD; trabodenoson 3.0% / latanoprost 0.005% QD FDC	Drug: trabodenoson 3.0% / latanoprost 0.005% QD; Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
EXPERIMENTAL: trabodenoson 6.0% /latanoprost 0.0025%QD; trabodenoson 6.0% /latanoprost 0.0025% QD FDC	Drug: trabodenoson 6.0% / latanoprost 0.0025% QD; Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
ACTIVE_COMPARATOR: latanoprost 0.005% QD; latanoprost 0.005% ophthalmic solution QD	Drug: latanoprost 0.005% QD; Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
ACTIVE_COMPARATOR: latanoprost 0.0025% QD; latanoprost 0.0025% ophthalmic solution QD	Drug: latanoprost 0.0025% QD; Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intraocular Pressure (IOP)	Daily change from diurnal baseline in IOP	Two Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Parameters, Including Treatment Emergent Adverse Events, to Assess Tolerability and Safety.	Collection of safety parameters, including treatment emergent adverse events, laboratory assessments, to assess tolerability and safety.	Through Study Completion, up to 9 weeks.

Collaborators and Investigators

• Sponsor: Inotek Pharmaceuticals Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 19, 2016
• Primary Completion (ACTUAL): May 24, 2017
• Study Completion (ACTUAL): May 31, 2017

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (ESTIMATE): July 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: ocular hypertension; glaucoma; primary open-angle glaucoma; adenosine agonist; eye drop; trabodenoson; trabecular meshwork
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: IPC-02-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO