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PURPOSETo compare the glare-type photic phenomena for a new intraocular lens (IOL) to other monofocal IOLs, and to investigate how IOL design features might affect these phenomena.SETTINGAlcon Laboratories, Inc., Fort Worth, Texas; John A Moran Eye Center, University of Utah, Salt Lake City, USA.DESIGNSchematic model eye evaluation and in vitro study.METHODSFive monofocal IOL models (Clareon CNA0T0, Tecnis ZCB00, enVista MX60, Eternity W-60, and Vivinex XY1) were used to evaluate glare or positive dysphotopsia-type phenomena. Optical simulations of incoming light were generated using nonsequential ray-tracing software based on a collimated light source for various off-axis angles of illumination. The simulation analyses were verified using a laboratory in vitro bench-top glare measurement system.RESULTSThe Clareon and Vivinex IOLs produced focused off-axis images with negligible peripheral glare characteristics. The Tecnis and enVista IOLs produced dispersed images with additional glare characteristics at 45 degrees of off-axis illumination and higher. The Eternity IOL showed the highest edge-reflected glare characteristic, likely because of its straight optic edge geometry. The laboratory bench images and glare intensity profiles were consistent with the simulation data.CONCLUSIONSIn vitro and nonsequential ray-tracing evaluations showed that straight optic edges and peripheral nonimaging optic geometry might contribute to positive dysphotopsia. The IOL designs with optic edge curvature and full functional optics demonstrated the lowest level of glare-type photic phenomena. Only clinical studies can confirm whether the differences observed between the IOLs in vitro are clinically significant.

25 Apr 2011·Journal of Biopharmaceutical StatisticsQ4 · MEDICINE

Multiple Testing Procedures in Two Pivotal Clinical Trials for Approval of a New Pharmaceutical Product

Q4 · MEDICINE

Article

Author: Wiens, Brian L.

We consider analysis of two identical pivotal trials with correlated multiple hypotheses evaluated by the fixed-sequence, weighted Holm, or fallback procedure. For approval, at least one hypothesis must be rejected in both studies. Various weights are considered for the fallback and weighted Holm procedure to provide separation in a single study. Evaluation of the procedures as closed tests distinguishes which has the highest power in different situations. No procedure is universally optimal. The best procedure depends on the power to reject the various hypotheses, something that is never known with certainty, and the goals of the analyses. If the most important goal is to demonstrate a difference on the first hypothesis or on all hypotheses, the fixed-sequence procedure performs best. However, the fixed sequence often has the highest chance of obtaining inconsistent results between the two independent studies, which makes it less appealing. The weighted Holm and fallback procedures are very similar, with various weighting schemes providing modest differentiation. The alpha exhaustive version of the fallback procedure often has higher power for some endpoints and lower power for other endpoints compared to the weighted Holm procedure, but the differences are rarely large.

01 Nov 2008·Advances in Therapy

Corneal staining reductions observed after treatment with Systane® Lubricant Eye Drops

Article

Author: Christensen, Mike T

INTRODUCTIONBecause of the added emphasis on ocular surface damage included in the Dry Eye Workshop's revised definition of dry eye, an evaluation of corneal staining reductions was conducted for propylene glycol/polyethylene glycol 400-based artificial tear drops (Systane Lubricant Eye Drops; Alcon Laboratories, Fort Worth, TX, USA).METHODSAn analysis was conducted on the percent change from baseline in mean corneal staining scores as reported in two previously published, randomized, double-masked, 6-week clinical studies of Systane. A descriptive comparison was also made between the outcome of the composite analysis and data obtained for Optivetrade mark Lubricant Eye Drops (Allergan, Inc., Irvine, CA, USA). Finally, results were reviewed for an open-label study that investigated corneal staining over a 5-week period after patients discontinued Systane therapy.RESULTSThe composite analysis included 107 Systane-treated patients. The results showed that Systane consistently reduced corneal staining at each visit; the percent change from baseline to day 42 (exit) was 47.1% (P<0.0001). After discontinuing Systane, immediate and significant increases in corneal staining were reported by 20 patients, with an overall increase from baseline to day 35 (exit) of 195.0% (P<0.0001).CONCLUSIONEvaluations of sum corneal ocular staining scores provide clinically meaningful evidence of dry eye severity, and are an important indicator of dry eye disease progression. The results of the composite analysis of two peer-reviewed studies indicate that Systane significantly reduced corneal staining (P<0.0001), indicating a reduction in the severity of dry eye. Finally, discontinuation of Systane results in a rapid increase in corneal staining that further confirms Systane's ability to maintain ocular surface health.

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Pipeline Snapshot as of 22 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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