Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG
Condition: Primary Open-Angle Glaucoma (POAG); Ocular Hypertension (OHT)
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: trabodenoson 6.0% / latanoprost 0.005% QD; trabodenoson 3.0% / latanoprost 0.005% QD; trabodenoson 6.0% / latanoprost 0.0025% QD; latanoprost 0.005% QD; latanoprost 0.0025% QD
Intervention description: 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 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 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.; Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.; Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
Intervention MeSH terms: Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glaucoma; primary open-angle glaucoma; ocular hypertension; adenosine agonist; eye drop; trabodenoson; trabecular meshwork

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.
    

Eligibility 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