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Satoshi Kinoshita, Kousuke Noda, Saori Takashina, Yoko Dong, Ikuyo Atsumi, Haruka Obata, Toru Matsunaga, Takeshi Ohguchi, Atsuhiro Kanda, Susumu Ishida; Safety Evaluation of Novel Drug Delivery Device, the Conjunctival Ring. Invest. Ophthalmol. Vis. Sci. 2014;55(13):482.
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© ARVO (1962-2015); The Authors (2016-present)
The conjunctival ring is a novel device designed for drug delivery to the posterior segment of the eye. Previously, we reported that the conjunctival ring efficiently delivers the antibiotics to the retinal and choroidal tissues compared with medicated conventional contact lens (ARVO 2010). In this study, we evaluated the safety of the conjunctival ring containing dexamethasone sodium phosphate (DSP) in mice and rabbits.
All animals were treated in accordance with the ARVO Statement for the Use of Animals in Ophthalmic and Vision Research. Conjunctival rings containing 5% DSP or vehicle (borate buffer) were placed on right and left eyes of C57BL/6J mice, respectively (n=6 eyes each). Twenty-four hours later, corneal fluorescein staining was graded according to the McDonald-Shadduck scoring system, ranging 0 to 4. Similarly, conjunctival rings immersed in 2% DSP, 0.2% DSP, or vehicle solution were placed on the eyes of New Zealand white rabbits for 12 hours per day (n=4 eyes each). As a control, 0.1% dexamethasone metasulfobenzoate sodium was topically administered to the eyes of rabbits 4 times a day (eye-drop group, n=4 eyes). Eight days after, the ocular injury was scored with the McDonald-Shadduck method and lens opacification was assessed with slit-lamp examination. Histologically, infiltration of inflammatory cells in bulbar conjunctiva was evaluated.
In mice, corneal fluorescein staining scores were 2 or less in each eye and no significant difference was observed between the 5% DSP group and vehicle group. In rabbits, the scores were 1 or less in all but 1 eye in the groups. There were no significant differences between the DSP groups and vehicle group. Also, there was no increase of ocular injury in the conjunctival ring groups compared with the eye-drop group, in which all eyes were scored as 0. No remarkable change in crystalline lenses was observed in any group. Histological examination showed a slight infiltration of inflammatory cells in the bulbar conjunctiva in 2 eyes of 0.2% DSP group.
No remarkable side effect of the conjunctival ring was observed in both animal experiments. Our data suggest that the conjunctival ring is a safe device as a drug delivery system.
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