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

NCT02829996 | Completed Phase 2 Results

• 1 other identifier: IPC-02-2015
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Open-Angle Glaucoma (POAG); Ocular Hypertension (OHT)

Keywords

glaucoma; primary open-angle glaucoma; ocular hypertension; adenosine agonist; eye drop; trabodenoson; trabecular meshwork

Outcome Measures

Primary Outcomes (1)

• Mean Intraocular Pressure (IOP)

  Daily change from diurnal baseline in IOP

  Two Months

Other Outcomes (1)

• Safety Parameters, Including Treatment Emergent Adverse Events, to Assess Tolerability and Safety.

  Through Study Completion, up to 9 weeks.

Study Arms (5)

trabodenoson 6.0% /latanoprost 0.005% QD

EXPERIMENTAL

trabodenoson 6.0% / latanoprost 0.005% QD FDC

Drug: trabodenoson 6.0% / latanoprost 0.005% QD

trabodenoson 3.0% /latanoprost 0.005% QD

EXPERIMENTAL

trabodenoson 3.0% / latanoprost 0.005% QD FDC

Drug: trabodenoson 3.0% / latanoprost 0.005% QD

trabodenoson 6.0% /latanoprost 0.0025%QD

EXPERIMENTAL

trabodenoson 6.0% /latanoprost 0.0025% QD FDC

Drug: trabodenoson 6.0% / latanoprost 0.0025% QD

latanoprost 0.005% QD

ACTIVE COMPARATOR

latanoprost 0.005% ophthalmic solution QD

Drug: latanoprost 0.005% QD

latanoprost 0.0025% QD

ACTIVE COMPARATOR

latanoprost 0.0025% ophthalmic solution QD

Drug: latanoprost 0.0025% QD

Interventions

trabodenoson 6.0% / latanoprost 0.005% QD DRUG

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.

trabodenoson 6.0% /latanoprost 0.005% QD

trabodenoson 3.0% / latanoprost 0.005% QD DRUG

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.

trabodenoson 3.0% /latanoprost 0.005% QD

trabodenoson 6.0% / latanoprost 0.0025% QD DRUG

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.

trabodenoson 6.0% /latanoprost 0.0025%QD

latanoprost 0.005% QD DRUG

Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

latanoprost 0.005% QD

latanoprost 0.0025% QD DRUG

Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

latanoprost 0.0025% QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
• Mean Intraocular pressure (IOP) of ≥25 and ≤34

You may not qualify if:

• 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

Sponsors & Collaborators

• Inotek Pharmaceuticals Corporation: lead

Study Sites (1)

Inotek Pharmaceuticals Corporation

Lexington, Massachusetts, 02421, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

trabodenoson; Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Roni Cohen
• Organization: Inotek Pharmaceuticals Corp.

rcohen@inotekpharma.com

781-676-2100

Study Officials

• Cadmus C Rich, MD,MBA,CPE

  Inotek Pharmaceuticals Corp.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 12, 2016
• Study Start: August 19, 2016
• Primary Completion: May 24, 2017
• Study Completion: May 31, 2017
• Last Updated: February 15, 2018
• Results First Posted: February 15, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)