Clinical trial NCT01026831 (phase 3, status: completed)
Conditions: open-angle glaucoma, ocular hypertension
ICD codes: H40.10X0, H40.10X1, H40.10X2, H40.10X3, H40.10X4, H40.1130, H40.1131, H40.053, H40.051, H40.052, H40.059
Drugs: preservative-free tafluprost, comparator: timolol
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(F)(F)COC1=CC=CC=C1, [H][C@](O)(CNC(C)(C)C)COC1=NSN=C1N1CCOCC1
Eligibility criteria:

        Inclusion Criteria:

          -  Patient has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma,
             capsular glaucoma/pseudoexfoliation, or ocular hypertension

          -  Patient has a mean (or median) IOP of >=23 and =<36 in at least one eye at the 0800
             hours time point at the Baseline Visit.

          -  Patient has <5 mmHg difference in mean (or median) IOP between eyes at each time point
             (0800 hours, 1000 hours, and 1600 hours) at Baseline.

          -  Patient is currently using a prescribed ocular hypotensive medication and has been on
             a stable dose for 30 days prior to screening, or patient is drug-naive (those who have
             never used or who have not used ocular hypotensive medication for at least 4 weeks
             prior to screening)

          -  Patient is able to safely discontinue current ocular hypotensive medication during up
             to the 4-week washout period

          -  Patient has vision corrected to 20/80 or better in each eye

          -  Patient is willing and able to avoid wearing contact lenses from 4 weeks prior to
             dosing through 24 hour after final dosing

          -  Patient is willing and able to self-administer or has an able person available on a
             daily basis to assist with administration of study medications

          -  Patient is not pregnant and not planning to become pregnant during the study

          -  Patient is male or female ≥18 of age on the day of signing the informed consent

        Exclusion Criteria:

          -  Patient is unable to use study medication in the affected eye(s)

          -  Patient has a history of inflammatory ocular surface disease or anterior or posterior
             uveitis in either eye

          -  Patient has a history of retinal detachment, diabetic retinopathy, or other
             progressive retinal disease

          -  Patient has experienced significant visual field loss within the last year

          -  Patient has had intraocular surgery in either eye in the last 4 months

          -  Patient has a history of glaucoma surgery or refractive surgery in either eye

          -  Patient is currently taking two or more anti-glaucoma medications (except Cosopt™ or
             its generic formulation)

          -  Patient has previously used tafluprost

          -  Patient has a history of cardiovascular disorder within 6 months prior to screening

          -  Patient has a history of bronchial asthma, wheezing, pneumonia, COPD, other pulmonary
             disease, or abnormal chest x-ray

          -  Patient has a mean (or median) IOP >36 mmHg in either eye at the Screening Visit or at
             any time point (0800 hours, 1000 hours, and 1600 hours) of the Baseline Visit.