Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: T-2345; Xalatan
Intervention description: T-2345 Ophthalmic Solution; Xalatan (latanoprost 0.005% ophthalmic solution)
Intervention MeSH terms: Latanoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 335.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary open angle glaucoma; Ocular hypertension

Summary:

      This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both
      eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84
      days in patients with elevated eye pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or older.

          2. POAG or OH with IOP treated and adequately controlled (IOP ≤ 18 mm Hg) with
             latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks prior to
             Screening.

          3. Each eye being treated with latanoprost 0.005% ophthalmic solution monotherapy must
             have mean IOP ≤ 18 mm Hg at Screening and mean IOP ≤ 28 mm Hg at Baseline;
             measurements will be taken at each visit at 8 AM, 10 AM, and 4 PM (each ± 30 minutes)
             with AM measurements of IOP at least 2 hours apart. If only one eye qualifies but both
             eyes have glaucoma and the fellow eye will require antiglaucoma medications, the
             subject does not qualify for the trial.

          4. Stable visual field (VF), defined as no sign of VF degradation between two consecutive
             30-2 or two consecutive 24-2 VF examinations. For subjects with no VF defect (eg,
             those with OH), a single, normal VF examination performed ˂ 6 months prior to the
             screening visit is allowed to determine eligibility. For patients who have an abnormal
             VF examination, the following criteria apply:

               -  Two VF (most recent VF and past VF) examinations performed at least ≥ 6 months
                  and ≤ 18 months apart must be compared;

               -  The most recent VF examination should be performed < 6 months prior to the
                  Screening visit;

               -  The past VF examination should be performed ≥ 6 months and ≤ 18 months prior to
                  the most recent VF test.

          5. Stable corrected Snellen visual acuity (VA) of better than 20/200 in the study eye.
             Patients must see ≥ 50% of the letters on a single line to accept that VA line.

          6. Central corneal thickness 480-620 μm in the study eye.

          7. Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes.

          8. Female subjects must be 1-year postmenopausal, surgically sterilized, or women of
             childbearing potential with a negative urine pregnancy test at Screening. Women of
             childbearing potential must use an acceptable form of contraception throughout the
             study. Acceptable methods include the use of at least one of the following:
             intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring),
             barrier with spermicide (condom, diaphragm), or abstinence.

          9. All subjects must provide signed written consent prior to participation in any
             study-related procedures.

        Exclusion Criteria:

        In the study eye:

          1. A mean deviation of < -20 dB on VF examination.

          2. A mean IOP ˃ 28 mm Hg at Baseline.

          3. Presence of a scotoma within 5° of fixation on VF examination.

          4. Aphakia.

          5. Use of any antiglaucoma medication in addition to latanoprost 0.005% ophthalmic
             solution within 2 weeks prior to Screening and any antiglaucoma medication (other than
             latanoprost) during the study period other than the randomized study medication.

          6. Use of any topical ophthalmic steroid within 2 weeks prior to Baseline. A short course
             of oral steroids is acceptable if the course is completed > 2 weeks prior to
             Screening. Inhaled and intranasal steroids are acceptable.

          7. Use of topical nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to
             Baseline.

          8. Use of any ophthalmic medications during the study period (nonpreserved artificial
             tears are allowed).

          9. Ocular surgery or laser treatment of any kind in the study eye within 3 months prior
             to Baseline.

         10. History of ocular allergy/inflammation and/or severe blepharitis and/or uveitis.
             Seasonal allergic conjunctivitis is acceptable (avoid enrollment of subjects who may
             experience seasonal flare-up during the study period). Mild
             blepharitis/blepharoconjunctivitis, typically associated with prostaglandin usage, on
             the lid is acceptable.

         11. History of ocular trauma or ocular infection within 3 months of Screening.

         12. History of herpes simplex keratitis.

         13. Current proliferative diabetic retinopathy or age-related macular degeneration, unless
             deemed not clinically significant by the Investigator.

         14. Severe dry eye (eg, clinically relevant superficial punctate keratitis, epithelial
             erosions of the cornea, and/or use of dry eye medication [including artificial tears]
             with a frequency exceeding 8 instillations per day).

         15. Contact lens wear during the study period. Contact lens wear in an untreated fellow
             eye is allowed.

         16. Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic
             glaucoma, or pseudoexfoliation syndrome).

         17. Any severe glaucoma defined by cupping (cup-to-disc ratio ≥ 0.8).

         18. Any non-laser glaucoma surgery.

         19. Any abnormality preventing accurate assessment (eg, resulting in unreliable
             applanation tonometry or VF examination).

             General:

         20. Pregnancy or lactation.

         21. Uncontrolled asthma (defined as asthma that does not respond to the maximum
             guideline-directed therapy).

         22. Allergy to benzalkonium chloride.

         23. History of moderate or severe renal or hepatic impairment.

         24. Participation in any study of an investigational product within 30 days prior to
             Screening or at any time during the study period.