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Almira Chabi, Robert Lupinacci, Christine Baranak, W. Joseph Herring; Randomized Clinical Trial Of The Efficacy And Safety Of Preservative-free Tafluprost And Preservative-free Timolol In Patients With Open-angle Glaucoma (OAG) Or Ocular Hypertension (OHT) In India. Invest. Ophthalmol. Vis. Sci. 2014;55(13):549.
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Prostaglandin analogs are frequently first-line IOP-lowering therapy in patients with OAG and OHT. Most topical ocular hypotensives contain the preservative benzalkonium chloride, which may be associated with decreased ocular tolerability in some patients. We compared the efficacy and safety of tafluprost, a preservative-free (PF) prostaglandin analog, with PF timolol in India.
Randomized, double-masked, Phase III clinical trial (NCT01254604) in patients with OAG and OHT. After discontinuation and washout of existing ocular hypotensive treatment, patients who had IOP ≥24 and ≤36 mmHg in at least 1 eye at the 0800 hr time point were randomized 1:1 to 4 weeks of treatment with either PF tafluprost (PF TAF) 0.0015% or PF timolol (PF TIM) 0.5%. IOP was measured 3 times during the day (0800, 1000, 1600 hrs) at baseline and weeks 2 and 4. The primary hypothesis was that PF TAF would be non-inferior to PF TIM in mean diurnal IOP change from baseline to week 4. The study was powered for a non-inferiority margin of 1.5 mmHg.
A total of 190 patients were randomized and 173 completed (PF TAF = 95, 87 and PF TIM = 95, 86 respectively). Baseline diurnal mean IOPs were 24.8 mmHg in the PF TAF group and 24.9 mmHg in the PF TIM group. IOPs at week 4 decreased a mean of -8.3 mmHg (95% CI ranged between -9.0 and -7.6) for PF TAF and decreased a mean of -6.6 mmHg (95% CI ranged between -7.3 and -5.9) for PF TIM. At weeks 2 and 4, the upper limits of the 2-sided 95% CIs for the difference between treatments in IOP-lowering were less than the pre-specified non-inferiority margin. In fact, the CIs were < 0 at both weeks 2 and 4 suggesting PF TAF superiority to PF TIM with respect to diurnal IOP change from baseline. The percentages of PF TAF and PF TIM patients reporting ocular pain/stinging/irritation and pruritus were (6.5% vs. 5.3%; nominal p=0.742) and (7.5% vs. 3.2%; nominal p=0.188) respectively. The percentages of PF TAF and PF TIM patients reporting conjunctival hyperemia (determined by aggregation of all terms suggestive of conjunctival hyperemia) were 9.7% vs. 4.3% (nominal p=0.145).
The IOP-lowering effect of PF tafluprost was non-inferior to that of PF timolol. PF tafluprost is an efficacious and generally well-tolerated ocular hypotensive agent.
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