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

NCT02829996 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2018-02-15

Study results available
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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)

Interventions

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.

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.

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.

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.

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.

Sponsors & Collaborators

  • Inotek Pharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Cadmus C Rich, MD,MBA,CPE · Inotek Pharmaceuticals Corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-19
Primary Completion
2017-05-24
Completion
2017-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02829996 on ClinicalTrials.gov