Double-masked Study of AR-13324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Condition: Ocular Hypertension; Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Timolol maleate Ophthalmic Solution 0.5% BID; AR-13324 Ophthalmic Solution 0.02%; Placebo
Intervention description: 1 drop BID, AM/PM, OU; 1 drop once daily (QD), PM, OU; 1 drop QD, AM, OU
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 411.0
Sex: All
Healthy volunteers: No
Keywords: Glaucoma

Summary:

      To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324
      Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic
      Solution, 0.5%
    

Eligibility criteria:

        Subject Inclusion criteria:

          1. 0-2 years of age and 18 years or greater.

          2. Diagnosis of open angle glaucoma or ocular hypertension

          3. Unmedicated (post-washout) IOP (Intraocular Pressure) >20 mm Hg and < 27 mm Hg in the
             study eye at 2 qualification visits.

          4. Corrected visual acuity in each eye equivalent to 20/200.

          5. Able and willing to give signed informed consent (parent or guardian consent for
             pediatric patient) and follow study instructions.

        Subject 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. Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes (individuals who are
             excluded for this criterion are not allowed to attempt requalification), or use of
             more than two ocular hypotensive medications within 30 days of screening. Note: fixed
             dose combinations count as two medications.

          3. Known hypersensitivity to any component of the formulations to be used (benzalkonium
             chloride, etc.), to topical anesthetics or beta adrenoceptor antagonists.

          4. Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye

          5. Refractive surgery in either eye.

          6. Ocular trauma in either eye within the six months prior to screening, or ocular
             surgery or non-refractive laser treatment within the three months prior to screening.

          7. Recent or current evidence of ocular infection or inflammation in either eye. Current
             evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes
             simplex or zoster keratitis at screening in either eye.

          8. Ocular medication in either eye of any kind within 30 days of screening.

          9. Clinically significant ocular disease in either eye (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.

         10. Central corneal thickness in either eye greater than 600 µm at screening.

         11. Any abnormality in either eye preventing reliable applanation tonometry of either eye.

             Systemic:

         12. Clinically relevant abnormalities (as determined by the investigator) in laboratory
             tests at screening which may impact the study.

         13. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists (e.g.,
             chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood
             pressure or heart rate; second or third degree heart block or congestive heart
             failure; severe diabetes).

         14. Clinically significant systemic disease (e.g., uncontrolled diabetes, 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 an effect on intraocular pressure
             within 30 days prior to screening, or anticipated during the study.

         17. 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.