ITT analysis IOP 22-34mmHg after washout PF TAF 0.0015% Corneal thickness (µm) Best corrected visual acuity score of +0.6 logMAR Right eye: 548.7 or better in each eye TAF administered once Left eye: 547.0 Product equivalency was established daily at 8pm Exclusions IOP >34; known allergy/hypersensitivity to study Patients treated for 4 meds; use of contact lenses at screening or during weeks then switched to study; prior filtration surgery or other ocular other arm after washout surgical procedures in past 6 months; any of at least 4 weeks condition preventing reliable applanation tonometry; advanced visual field defect, active external ocular disease; inflammation or infection of the eye or eyelids within 3 months; ocular presence of any uncontrolled systemic disease; pregnant or breastfeeding Appendix 2: Switch studies Study Entry Criteria Intervention Demographic/Baseline data Results Uusitalo 2010 Inclusions Latanoprost→tafluprost PF Age (yrs): 68.9 Open-label; all Primary open-angle glaucoma, capsular glaucoma or Females (%): 65.8 patients switched ocular hypertension Duration of latanoprost (yrs): 12-weeks Tx with latanoprost ≥ 6months IOP, symptoms and signs, 3.3 [0.4, 12.7]
ITT analysis IOP 22-34mmHg after washout Best corrected visual acuity score of +0.6 logMAR or better in each eye Exclusions IOP >34; known allergy/hypersensitivity to study meds; use of contact lenses at screening or during study; prior filtration surgery or other ocular surgical procedures in past 6 months; any condition preventing reliable applanation tonometry; advanced visual field defect, active external ocular disease; inflammation or infection of the eye or eyelids within 3 months; ocular presence of any uncontrolled systemic disease; pregnant or breastfeeding PF TAF 0.0015% TAF administered once daily at 8pm Patients treated for 4 weeks then switched to other arm after washout of at least 4 weeks Corneal thickness (µm) Right eye: 548.7 Left eye: 547.0 Product equivalency was established Appendix 2: Switch studies Study Entry Criteria Intervention Demographic/Baseline data Results Uusitalo 2010 Open-label; all patients switched 12-weeks Inclusions Primary open-angle glaucoma, capsular glaucoma or ocular hypertension Tx with latanoprost ≥ 6months Latanoprost→tafluprost PF IOP, symptoms and signs, Age (yrs): 68.9 Females (%): 65.8 Duration of latanoprost (yrs): 3.3 [0.4, 12.7]
Tafluprost_Ophthalmic_Solution_Monograph.docx