Clinical trial NCT01474135 (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: 0.25% ar-12286 / 0.004% travoprost, 0.5% ar-12286, 0.004% travoprost, 0.004% travoprost
SMILES: CC(C)OC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1\C=C\[C@@H](O)COC1=CC=CC(=C1)C(F)(F)F, CC(C)OC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1\C=C\[C@@H](O)COC1=CC=CC(=C1)C(F)(F)F, CC(C)OC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1\C=C\[C@@H](O)COC1=CC=CC(=C1)C(F)(F)F
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) IOP ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days
             apart. At second eligibility visit, IOP >22 mmHg at 10:00, 12:00 and 16:00 hrs.

          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 (in either eye):

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

          2. Intraocular pressure > 36 mm Hg

          3. Known hypersensitivity to travoprost, 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).

          5. Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).

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

          7. History or evidence of ocular infection, inflammation, clinically significant
             blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis

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

          9. Ocular medication of any kind within 30 days of Visit 1, 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 1) or c)
             lubricating drops for dry eye (which may be used throughout the study).

         10. 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 (i.e., cup-disc ratio > 0.8).

         11. Central corneal thickness greater than 600 µ.

         12. Any abnormality preventing reliable applanation tonometry of either eye.

             Systemic:

         13. Clinically significant abnormalities in laboratory tests at screening.

         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 the past 30 days.

         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 status of nonclinical 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.

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