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Charles D Leahy, Rodney Gutner, Whittney Varney, Jack Rulander, Stephen Johnston, Francis Lai, Kathryn S Crawford, Jeanne Ellis, Edward Ellis; Continuous Wear Non-Invasive Device for Sustained Ocular Drug Delivery. Invest. Ophthalmol. Vis. Sci. 2014;55(13):481.
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Topical ocular drug delivery devices have a history of being too small to deliver useful drug doses or of having significant retention and comfort issues. The purpose of this study was to demonstrate feasible safety, comfort and retention of one size of a non-invasive topical device of substantial volume (110 mm3) worn for an extended period of continuous wear under the lid on the superior sclera.
An open label, 5-visit study evaluating safety, appearance, tolerability and retention of a vehicle (non-drug containing) device (TODDD™) was conducted at the New England College of Optometry. At Visit 1 the device was placed on 1 eye. Subjects who exhibited acceptable stability and comfort then wore the device continuously for 4 weeks. Subsequent visits were at 2 (via phone), 7, 14, 21, and 28 ± 2 days. Safety evaluations at each in-office visit included VA, and slit-lamp, with grading of any hyperemia or fluorescein and lissamine green staining. Subjects reported on comfort, positioning, removal or ejection of the device and other observations at each visit.
14 adult subjects (10 female, 4 male,) were dispensed a device, with 10 subjects completing the study, wearing the device 24/7 for 4 consecutive weeks. In the 10 completed subjects, the device retained its position on the superior sclera, completely under the lid, with good stability and movement. There were no visual changes or other significant safety findings related to device wear. Subjects reported good tolerability and comfort. The four subjects who did not complete the study had suboptimal stability that became more pronounced by the first night of wear; three of these exited within the first 24 hr. The fourth subject continued wear for another week, but noticed instability during vigorous sports, leading to redness (grade 3) from repeated manipulation of the device, which cleared soon after the device was removed. Subjects reported that the device was as convenient as or easier to use than a contact lens.
Results in this human subject population indicate that this large device is well-tolerated under the lid during continuous wear. Retention and comfort were demonstrated in over 70% of subjects using only a single device size, with success being predictable based on comfort and stability during the first 24 hr. The device produced no safety concerns after 4 weeks of continuous wear
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