April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Investigation of Corneal Effects of Taprenepag Isopropyl (PF-04217329) by Confocal Microscopy
Author Affiliations & Notes
  • Ronald A. Schachar
    Ophthalmology, Pfizer Global Research and Development, San Diego, California
  • Susan Raber
    Ophthalmology, Pfizer Global Research and Development, San Diego, California
  • Min Zhang
    Ophthalmology, Pfizer Global Research and Development, San Diego, California
  • Scott Howell
    Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, Ohio
  • Beth Ann Benetz
    Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, Ohio
  • Kristina Thomas
    Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, Ohio
  • Loretta Szczotka-Flynn
    Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, Ohio
  • Jonathan Lass
    Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, Ohio
  • Footnotes
    Commercial Relationships  Ronald A. Schachar, Pfizer (E); Susan Raber, Pfizer (E); Min Zhang, Pfizer (E); Scott Howell, None; Beth Ann Benetz, Glaukos (R), Glaukos, Pfizer, Transcend Medical, Eyetech (F); Kristina Thomas, Allergan, Pfizer (R); Loretta Szczotka-Flynn, Alcon Laboratories, Bausch & Lomb (R); Jonathan Lass, Glaukos (R), Glaukos, Pfizer, Transcend Medical, Eyetech (F)
  • Footnotes
    Support  Research supported by Pfizer Inc.
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 228. doi:
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      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.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : To evaluate the corneal effects of taprenepag alone (TAP) and in an unfixed combination with latanoprost (LAT).

Methods: : 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.

Results: : 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.

Conclusions: : 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: : http://www.clinicaltrials.gov NCT00934089

Keywords: cornea: endothelium • cornea: epithelium • imaging/image analysis: clinical 
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