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Charles Leahy, Rodney Gutner, Whittney Varney, Jack Rulander, Stephen Johnston, Francis Lai, Kathryn Crawford, Roger Albright, Jeanne Ellis, Edward Ellis; A Pilot Safety Assessment of a Topical Ocular Device (TODDD™) Intended for Sustained Drug Delivery. Invest. Ophthalmol. Vis. Sci. 2013;54(15):1078.
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To establish safety, comfort and retention of TODDD for continuous wear studies. Although intended to deliver drug while worn on the superior sclera 24/7 for several months at a time, in this early stage human study it was without drug and worn 12-15 hr/day for 1 week.
An open label study evaluating safety, retention and subjective symptoms of comfort of the TODDD was conducted at the New England College of Optometry. At Visit 1 device was placed on one eye and subjects were instructed on insertion and removal procedures. They then wore the single device daily (12-15 hr) for 7±2 days until Visit 2. Safety evaluations on each visit included VA, keratometry, and slit-lamp grading and any fluorescein and lissamine green staining using the Brien Holden V. I. Grading Scales. Fit, stability and integrity of the device were observed. Subjects reported on comfort, positioning, and ejection of the device at each visit, and each evening after device removal via electronic diary.
12 (11 females and 1 male, age 24-26) of 14 screened subjects were dispensed the device and all 12 completed the study. There were no significant adverse events or safety findings. Slit lamp grades after 1-4 hours and 1 week of wear showed increases of 0 or 1 across all categories in either eye, and grade 0 or 1 conjunctival staining was reported in all subjects at all examinations, but for one subject, who had grade 3 lissamine staining of the conjunctiva at Visit 2. There were no lid gradings above 2, and no corneal findings above grade 1 in any subject. In the majority of subjects at all time points, the device positioned on the superior sclera without excess rotation, completely under the lid, with good stability and movement. The devices remained clean and intact. At Visit 1 only mildly decreased ocular comfort associated with some awareness of device was reported. At Visit 2 all but 1 subject reported comfortable wear always or most of the time. No devices spontaneously ejected from the eye or were lost. Among prior contact lens wearers, most subjects considered the device handling “comparable to contact lens”.
This preliminary study indicates that the device is well-tolerated in this subject population. Retention was demonstrated and the device produced no safety concerns after 7 days of daily wear. Continuous wear studies are planned.
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