Study of AR-13324 in Patients With Elevated Intraocular Pressure
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: AR-13324 Ophthalmic Solution 0.01%; AR-13324 Ophthalmic Solution 0.02%; AR-13324 Ophthalmic Solution 0.04%; AR-13324 Ophthalmic Solution Vehicle
Intervention description: Administered to study eye, once daily (QD) in the morning (AM) for 7 days; Administered to study eye, QD AM for 7 days; Administered to study eye, QD AM for 7 days; Administered to study eye, QD AM for 7 days
Intervention MeSH terms: Pharmaceutical Solutions; 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: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Intraocular pressure; visual field; Ocular hypertension or open angle glaucoma

Summary:

      In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized
      to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye),
      once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be
      administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated
      in the clinic throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or greater. 18 years of age or greater.

          2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).

          3. Unmedicated (post-washout, p.r.n.) IOP ≥ 24 mm Hg in one or both eyes at 08:00 hours,
             ≥ 21 mm Hg at 10:00, 12:00 and 16:00 hours on post-washout measurement (Visit 1).

          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: Either eye

          1. Intraocular pressure > 36 mm Hg

          2. Known hypersensitivity to any component of the formulation or to topical anesthetics,
             (benzalkonium chloride, etc.)

          3. Ocular trauma within the past six months, or ocular surgery or laser treatment within
             the past three months.

          4. Evidence of ocular infection, inflammation, clinically significant blepharitis or
             conjunctivitis at baseline (Visit 1), or history of herpes simplex keratitis.

          5. Contact lens wear within 30 minutes of instillation of study medication.

          6. Ocular medication of any kind within 30 days of Visit 2, 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 2) or c)
             lubricating drops for dry eye (which may be used throughout the study),

          7. Clinically significant ocular disease (e.g. corneal edema, 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 (e.g., advanced glaucomatous optic nerve head or visual field
             loss).

          8. Any abnormality preventing reliable applanation tonometry in either eye. Study eye:

          9. Glaucoma: pseudoexfoliation or pigment dispersion component, history of acute
             angle-closure glaucoma, or closed or narrow angle upon gonioscopy. Note: Previous
             laser peripheral iridotomy is NOT acceptable.

         10. Previous glaucoma intraocular surgery or laser procedures such as argon laser
             trabeculoplasty (ALT), selective laser trabeculoplasty (SLT) or micropulse laser
             trabeculoplasty ( MLT), as well as refractive procedures such as radio keratotomy
             (RK), laser eye surgery (LASIK), photorefractive keratectomy (PRK), or collagen cross
             linking.

         11. Central corneal thickness greater than 600 μm.

             General/Systemic:

         12. Clinically significant abnormalities in laboratory tests at screening, recognizing
             that subjects are not fasting at the time of drawing blood.

         13. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia
             gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere
             with the study.

         14. Participation in any investigational study within the past 30 days.

         15. Changes of systemic medication during the study that could have a substantial effect
             on IOP within 30 days prior to screening, or anticipated during the study.

         16. Due to status of 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.