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Jean-Francois J. Rouland, T2345 study group; Efficacy And Safety Of T2345, Preservative Free Latanoprost Eyedrops, Compared To XalatanTm In Patients With Ocular Hypertension Or Glaucoma. Invest. Ophthalmol. Vis. Sci. 2012;53(14):5099.
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To compare IOP-lowering effect and safety of preservative free latanoprost to BAK-preserved Latanoprost (Xalatan™) in patients with ocular hypertension or glaucoma.
This prospective, international, multicenter, randomized, investigator-masked, parallel groups study included 402 patients with chronic primary open angle glaucoma (POAG) or ocular hypertension (OHT). Males or females aged from ≥ 18 to ≤ 90 years old with POAG or OHT, already treated and controlled by monotherapy with Xalatan™ were randomized to receive either preservative free latanoprost (T2345) or preserved latanoprost (Xalatan™) for 3 months. After a 5-week run-in period with twice a day (morning and evening) brinzolamide 0.15mg/mL and a 5-day wash-out period, patients were to instill one drop into the affected eye(s) once daily at 9:00 pm ± 1 hour. Visits were for selection (D-42), inclusion on D0, and follow-up on D15, D42 and D84. Main outcome measure was the change in IOP at 9:00 am (± 1h) between the baseline and D84 in the worse eye. Safety parameters were also reported.
The mean IOP reduction from baseline on D84 was -8.6 ± 2.6 mmHg (-36%) on preservative free latanoprost and -9.0 ± 2.4 mmHg (-38%) on preserved latanoprost. These results met the limits set for non-inferiority. Similar results were observed as soon as D15. The investigator assessed the efficacy of the study medication as "very satisfactory" or "satisfactory" for at least 96% of patients in each treatment group at each visit. The most frequent ocular AE was drug intolerance which was reported in 1 (0.5%) patient in the preservative free latanoprost group versus 4 (2.1%) patients receiving preserved latanoprost. Overall conjunctival hyperemia was less frequent on preservative free latanoprost than on the preserved formulation, at D42 and D84 (20% versus 30%). Subjective ocular symptoms scores upon instillation were significantly lower among those receiving preservative free latanoprost on D42 (p=0.001) and D84 (p=0.001).
This preservative free formulation of latanoprost provides the same efficiency as Xalatan™, with better local tolerability. It appears to be a promising therapeutic alternative to preserved topical anti-glaucoma drugs, well known for causing ocular surface damages during long term use.
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