Clinical trial NCT01302249 (phase 2, status: completed)
Conditions: glaucoma, ocular hypertension
ICD codes: H40.9, Q15.0, B73.02, H40.823, H40.89, H44.513, H40.821, H40.053, H40.051, H40.052, H40.059
Drugs: latanoprost 0.005%, ar-12286 ophthalmic solution 0.5%, timolol maleate ophthalmic solution 0.5%
SMILES: CC(C)OC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1CC[C@@H](O)CCC1=CC=CC=C1, [H][C@](O)(CNC(C)(C)C)COC1=NSN=C1N1CCOCC1
Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or greater.

          -  Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).

          -  Currently using prostaglandin analogue (monotherapy or combination therapy) O.U. ≥ 1
             month at time of study entry (first qualification visit) in study eye(s).

          -  Qualification Visit 1 (Screening) IOP at 16:00 hrs: PG monotherapy patients: ≥ 18 mm
             Hg; Combination therapy patients: >= 16 mm Hg. Qualification Visit 2 (post latanoprost
             run-in) IOP ≥ 20 mm Hg at 08:00 hrs and 10:00 hrs, IOP ≥ 18 mm Hg at 16:00 hrs in
             study eye(s). (Note: combination therapy may include any combination of topical ocular
             hypotensive agents).

          -  Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye
             (equivalent to 20/200).

          -  Able and willing to give signed informed consent and follow study instructions

        Exclusion Criteria:

        In either eye:

          -  Previously randomized to treatment in a clinical study of AR-12286.

          -  Intraocular pressure > 36 mm Hg.

          -  History of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy

          -  Known hypersensitivity or contraindication to timolol maleate ophthalmic solution, or
             any component of the formulation (benzalkonium chloride, etc.), or to topical
             anesthetics, including history of conjunctival hyperemia with topical latanoprost of
             severity greater than 1 on a 0-3 scale.

          -  Ocular trauma within the past six months, or ocular surgery or laser treatment within
             the past three months.

          -  Contact lens wear within 30 minutes of instillation of study medication.

          -  PG monotherapy patients: Ocular hypotensive medication (other than prostaglandin)
             within 4 weeks of Visit 0 (Study entry, first qualification visit). Combination
             therapy patients: Ocular hypotensive medication (other than prostaglandin and current
             additional agent) within 4 weeks of Visit 0 (Study entry, first qualification visit).

          -  Conjunctival hyperemia of grade 2+ or greater at Visit 1.

          -  Any other ocular medication within 4 weeks of Visit 1 with the exception of
             lubricating drops for dry eye (which may be used throughout the study).

          -  Clinically significant ocular disease (e.g. corneal edema, uveitis, severe
             keratoconjunctivitis sicca) which might interfere with the study, including
             glaucomatous damage so severe that treatment with only latanoprost for two periods of
             up to 4 weeks is not judged safe (e.g., advanced glaucomatous optic nerve head or
             visual field loss).

          -  Any abnormality preventing reliable applanation tonometry of either eye.

        In study eye(s):

          -  Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure.
             Note: Previous laser peripheral iridotomy is acceptable.

          -  Previous glaucoma intraocular surgery or laser procedures.

          -  Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

          -  Central corneal thickness greater than 600 µ.

        Systemic:

          -  Known bronchial asthma (history or current), severe chronic obstructive pulmonary
             disease, sinus bradycardia, second or third degree atrioventricular block or overt
             cardiac failure.

          -  Clinically significant abnormalities in laboratory tests at screening, recognizing
             that subjects are not fasting at the time of drawing blood.

          -  Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia
             gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere
             with the study.

          -  Participation in any investigational study within the past 30 days.

          -  Changes of systemic medication that could have a substantial effect on IOP 4 weeks
             prior to screening, or anticipated during the study.

          -  Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or
             not using a medically acceptable form of birth control.