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M. Aihara, H. Oshima, M. Araie, EXTraKT study group; Effect of Xalatan and TravatanZ on Keratoconjunctival Tissue (EXTraKT) Study - Prospective Multicenter Randomized Single Masked Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2010;51(13):167. doi: https://doi.org/.
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Benzalkonium chloride (BAK) has detrimental effects on the ocular surface. TravatanZ® (TRZ, travoprost 0.004%) replaces BAK by an ionic buffered system, sofZia®. In the basic research, BAK-free TRZ showed less damage to keratoconjunctival culture cells compared to control solutions including BAK. The purpose of this study is to compare the effect of Xalatan® (XAL) and BAK-free TRZ on the ocular surface of glaucoma patients in a prospective randomized multicenter single masked study design.
186 OAG or OH patients treated with XAL monotherapy at least for 3 months were enrolled from 23 institutions. The subjects were randomly allotted XAL group continuously treated with XAL or TRZ group treated with TRZ instead of XAL, and observed for 3 months. At enrollment, 1 and 3 months after enrollment, conjunctival hyperemia, superficial punctate keratitis (SPK) stained with fluorescein, conjunctival epithelial damage stained with Lissamin Green, tear break up time (TBUT), and intraocular pressure (IOP) were determined by a masked manner and further evaluated by the third party. SPK and conjunctival staining were scored by NIH classification.
At every 3 visits, there was no significant difference in hyperemia, conjunctival damage, TBUT, and IOP between the two groups. SPK was significantly improved at 3 months in the whole cornea (p=0.004), especially in the temporal and nasal sides (p=0.024 and 0.009, respectively) only in the TRZ group.
BAK-free TRZ has less detrimental effect on the corneal surface of glaucoma patients compared to XAL.
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