A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
Condition: Open-angle Glaucoma, Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution; Topical ultra-low dose of DE-126 Ophthalmic Solution; Topical low dose of DE-126 Ophthalmic Solution; Topical medium dose of DE-126 Ophthalmic Solution; Topical high dose of DE-126 Ophthalmic Solution; 0.005% Latanoprost Ophthalmic Solution
Intervention description: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks; Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks; Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks; Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks; Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks; 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
Intervention MeSH terms: Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma

Summary:

      Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop
      medications has been shown to be effective in delaying or preventing the progression of
      glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field
      loss.

      This study is being conducted to determine how well DE-126 ophthalmic solution works
      (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate
      the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost
      (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension.

      The IOP will be measured at 3 different times throughout the day, over 6 total visits during
      a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop
      taking current eye drops to lower IOP). Safety assessments will be done throughout the study,
      including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the
      most important time-point to measure IOP in this study and evaluate efficacy will be at the
      final study visit (month 3), IOP values will also be evaluated at other visits throughout the
      3-month treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide signed written informed consent

          -  Diagnosis of POAG or OHT in both eyes

          -  Qualifying corrected visual acuity in each eye

          -  Qualifying central corneal thickness in each eye

          -  Qualifying Day 1 IOP measurement at 3 time-points in both eyes

          -  Qualifying Anterior chamber angle

        Exclusion Criteria:

          -  History of ocular surgery specifically intended to lower IOP

          -  Subjects who cannot safely discontinue use of ocular hypotensive medications during
             the wait/washout period

          -  Advanced glaucoma in either eye

          -  Any corneal abnormality or other condition interfering with or preventing reliable
             Goldmann applanation tonometry

          -  Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1
             (Screening) and throughout the study in either eye

          -  Females who are pregnant, nursing, or planning a pregnancy