Purchase this article with an account.
Ronald A. Schachar, Susan Raber, Min Zhang, Scott Howell, Beth Ann Benetz, Kristina Thomas, Loretta Szczotka-Flynn, Jonathan Lass; Investigation of Corneal Effects of Taprenepag Isopropyl (PF-04217329) by Confocal Microscopy. Invest. Ophthalmol. Vis. Sci. 2011;52(14):228.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To evaluate the corneal effects of taprenepag alone (TAP) and in an unfixed combination with latanoprost (LAT).
Randomized, single-masked, crossover study of 14 days of TAP 0.01% alone and with LAT 0.005% at 8AM in 32 ocular hypertensive or glaucoma patients (24 non-Japanese and 8 Japanese) with baseline 8 AM IOP of ≥22mmHg and corneal thickness ≤600 µm. Sequential corneal staining and pachymetry assessed at the site, and confocal microscopic images (Confoscan 4, Nidek) assessed in a masked fashion at a central reading center was performed at baseline, days 7 and 13 on treatment, and day 35.
After washout, 30 subjects were treated. The incidence of treatment-related mild corneal staining was 69% and 63% for TAP and TAP+LAT, respectively and a limited number of superficial epithelial images of sufficient quality showed cell enlargement and irregularity with both treatments. A statistically significant mean increase from baseline of 26 µm and 23 µm in corneal thickness were observed on Day 7 and 13, respectively, for each treatment; which decreased on Day 35 to ≤6 µm. No statistically significant changes from baseline to all time points were observed in: corneal basal epithelium cell density; mid-stromal keratocyte cell density; endothelial cell density, cell area, coefficient of variation, or % hexagonal cells. There was no significant association of changes in corneal thickness with changes in densities of basal epithelium, mid-stromal keratocytes or endothelium. The mean ratio of average reflectivity of the anterior stroma to the mid-stroma at baseline was ~ 1.5. A significant ≥20% increase in the ratio was observed in period 1 for each treatment on Day 13 and 35 and this increase persisted during the second period.
Despite a transient increase in corneal thickness, there was no evidence by confocal microscopy of TAP toxicity to the basal epithelium, mid-stromal keratocytes, or endothelium. Mild corneal staining and disturbance of superficial corneal epithelium may explain the increase in anterior stromal reflectivity.
Clinical Trial: :
This PDF is available to Subscribers Only