Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
Intervention: AR-13324 Ophthalmic Solution 0.01%; AR-13324 Ophthalmic Solution 0.02%; Latanoprost ophthalmic solution 0.005%
Intervention description: Administered to study eye, once daily (QD) in the evening (PM) for 28 days; Administered to study eye, QD in the PM for 28 days; Administered to study eye, QD in the PM for 28 days
Intervention MeSH terms: Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Glaucoma

Summary:

      Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison
      of AR-13324 to latanoprost
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or greater.

          2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).

          3. Unmedicated (post-washout) Intraocular Pressure (IOP) ≥ 24 mm Hg at 2 eligibility
             visits (08:00 hr), 2-7 days a part, and ≥ 22 mm Hg at 10:00 and 16:00 hrs at the
             second qualification visit. If only one eye meets the IOP criteria it must be the same
             eye that met the criteria at all the qualification timepoints.

          4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye
             (equivalent to 20/200).

          5. Able and willing to give signed informed consent and follow study instructions.

        Exclusion Criteria:

        Ophthalmic

          1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure
             or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.

          2. IOP > 36 mm Hg.

          3. Known hypersensitivity to any component of the formulation (benzalkonium chloride,
             etc.), or to topical anesthetics.

          4. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s,
             e.g., laser trabeculoplasty).

          5. Refractive surgery in study eye(s) (e.g., radial keratotomy, photorefractive
             keratectomy (PRK), laser eye surgery (LASIK), etc.).

          6. Ocular trauma within the past six months, or ocular surgery or laser treatment within
             the past three months prior to screening.

          7. Evidence of ocular infection, inflammation, clinically significant blepharitis or
             conjunctivitis at screening (Visit 0), or a history of herpes simplex keratitis

          8. Ocular medication of any kind within 30 days of Visit 0, with the exception of a)
             ocular hypotensive medications (which must be washed out according to the provided
             schedule), b) lid scrubs (which may be used prior to, but not after Visit 0) or c)
             lubricating drops for dry eye (which may be used throughout the study).

          9. Clinically significant ocular disease (e.g. uveitis, severe keratoconjunctivitis
             sicca) which might interfere with the study, including glaucomatous damage so severe
             that washout of ocular hypotensive medications for one month is not judged safe (i.e.,
             cup-disc ratio > 0.8).

         10. Central corneal thickness greater than 600 µm.

         11. Any abnormality preventing reliable applanation tonometry of either eye.

             Systemic:

         12. Clinically significant abnormalities (as determined by the treating physician) in
             laboratory tests at screening.

         13. Known hypersensitivity or contraindication to latanoprost.

         14. Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal,
             endocrine or cardiovascular disorders) which might interfere with the study.

         15. Participation in any investigational study within 30 days prior to screening.

         16. Changes of systemic medication that could have a substantial effect on IOP within 30
             days prior to screening, or anticipated during the study.

         17. Due to the current status of the preclinical safety program, women of childbearing
             potential who are pregnant, nursing, planning a pregnancy, or not using a medically
             acceptable form of birth control. An adult woman is considered to be of childbearing
             potential unless she is one year post-menopausal or three months post-surgical
             sterilization. All females of childbearing potential must have a negative urine
             pregnancy test result at the screening examination and must not intend to become
             pregnant during the study.