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Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inotek Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT02829996
First received: July 8, 2016
Last updated: June 6, 2017
Last verified: June 2017
  Purpose

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.


Condition Intervention Phase
Primary Open-Angle Glaucoma (POAG) Ocular Hypertension (OHT) 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 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Inotek Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) [ Time Frame: Two Months ]

Other Outcome Measures:
  • Safety Parameters, including treatment emergent adverse events, to assess tolerability and safety. [ Time Frame: Through Study Completion, up to 9 weeks. ]

Enrollment: 201
Actual Study Start Date: August 19, 2016
Study Completion Date: May 31, 2017
Primary Completion Date: May 24, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trabodenoson 6.0% / latanoprost 0.005% QD
trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination
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% Fixed-Dose Combination
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% Fixed-Dose Combination
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
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02829996

Locations
United States, Massachusetts
Inotek Pharmaceuticals Corporation
Lexington, Massachusetts, United States, 02421
Sponsors and Collaborators
Inotek Pharmaceuticals Corporation
Investigators
Study Director: Cadmus C Rich, MD,MBA,CPE Inotek Pharmaceuticals Corp.
  More Information

Responsible Party: Inotek Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT02829996     History of Changes
Other Study ID Numbers: IPC-02-2015
Study First Received: July 8, 2016
Last Updated: June 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Inotek Pharmaceuticals Corporation:
glaucoma
primary open-angle glaucoma
ocular hypertension
adenosine agonist
eye drop
trabodenoson
trabecular meshwork

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Latanoprost
Pharmaceutical Solutions
Antihypertensive Agents

ClinicalTrials.gov processed this record on August 17, 2017