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QLT announces interim data from a Phase II clinical trial and a device study for the Punctal Plug Drug Delivery System
Date:7/28/2009

uates the effect of artificial tears preserved with benzalkonium chloride (AT-BAK) on IOP response to L-PPDS; 22 patients are currently enrolled and enrollment is continuing. The second trial compares IOP and safety outcomes based on L-PPDS placement (upper or lower punctum); enrollment is complete with 30 patients, and follow-up is ongoing.

The Device Study (Punctal Plug Prototype Designs)

This study is an ongoing, device, open-label, multicenter study conducted to investigate the safety, tolerability, comfort, ease of handling and insertion/removal, and retention of punctal plug prototype designs, in healthy subjects. Subjects are fitted with a punctal plug in each eye and wear the devices for 24 hours, after which the plugs are removed and replaced. Subjects then wear the devices for up to 12 weeks. Enrollment is ongoing. The preliminary overall retention rate of 75% after eight weeks of follow-up is based on a baseline sample of 447 eyes from 239 subjects who were fitted with prototypes from one family of designs. Subject comfort ratings for this design family are high (mean of 97 on a scale of 0-100 at Week 8), and physician handling assessments indicate that the devices are easy to insert and remove. Interim analyses show that these designs have been well tolerated. The most frequently reported adverse events for subjects fit with this family of designs have been increased lacrimation, eye irritation, and device migration (2.1% for each event); conjunctival hyperemia (1.7%); and conjunctival edema and eye disorder (1.3% for each event). Interim analyses of all punctal plug prototype designs in 590 subjects show that the most frequently reported adverse events overall have been device migration (3.7%), conjunctival hyperemia (1.3%), and eye irritation (1.0%).

Prototype punctal plug designs continue to be refined and evaluated to meet our retention criteria and converge with the identification of a dose formulation to pr
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SOURCE QLT Inc.
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