June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
POOLED ANALYSIS OF 2 CONFIRMATORY TRIALS EVALUATING THE EFFICACY AND SAFETY OF OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.77% USING A CONJUNCTIVAL ALLERGEN CHALLENGE MODEL
Author Affiliations & Notes
  • Eugene B McLaurin
    Total Eye Care, P.A., Savannah, GA
  • Abhijit Narvekar
    Alcon Research Ltd, Fort Worth, TX
  • Adeniyi Adewale
    Alcon Research Ltd, Fort Worth, TX
  • Paul J Gomes
    Ora, Inc., Andover, MA
  • Gail Torkildsen
    Andover Eye Associates, Andover, MA
  • Footnotes
    Commercial Relationships Eugene McLaurin, Alcon (R), Allergen (R); Abhijit Narvekar, Alcon (E); Adeniyi Adewale, Alcon (E); Paul Gomes, Alcon (C), Ora, Inc. (E); Gail Torkildsen, Alcon (F), Alcon (R), Allergan (F), Ora, Inc (C)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 4891. doi:
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      Eugene B McLaurin, Abhijit Narvekar, Adeniyi Adewale, Paul J Gomes, Gail Torkildsen; POOLED ANALYSIS OF 2 CONFIRMATORY TRIALS EVALUATING THE EFFICACY AND SAFETY OF OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.77% USING A CONJUNCTIVAL ALLERGEN CHALLENGE MODEL. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4891.

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

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Abstract
 
Purpose
 

Two phase 3 studies with similar designs were conducted to evaluate the efficacy and safety of olopatadine 0.77% (HDO) for the treatment of allergic conjunctivitis (AC). The objective of this pooled analysis was to evaluate the integrated efficacy and safety findings from a larger dataset.

 
Methods
 

Data were pooled from 2 similarly designed, randomized, multicenter, double-masked, active (olopatadine 0.1% & 0.2%) and vehicle controlled, parallel-group studies which used the Conjunctival Allergen Challenge (CAC) model. The study designs were identical except that one of the studies had an additional 16 hour duration efficacy evaluation visit and the other had an additional active comparator, olopatadine 0.1%. Eligible patients in both studies were ≥18 years with a history of AC. The pooled analysis employed a mixed model repeated measures ANOVA statistical method. The primary hypotheses were that HDO is superior to Vehicle (at onset of action & 24 hour duration CACs) and olopatadine 0.2% (at 24 hour duration CAC) with respect to ocular itching (OI) score evaluated at 3 time points (3, 5 & 7 minutes post-CAC).

 
Results
 

Data from a total of 448 patients were included in the analysis. Baseline and demographic characteristics were similar between HDO (n=164), olopatadine 0.2% (n=167) and Vehicle (n=117) groups. HDO was superior to Vehicle (p<0.0001) for OI at all 3 post-CAC time points at onset & 24 hours duration (avg. treatment differences [over the 3 post-CAC time points] were -1.44 and -1.30 at onset and 24 hours duration, respectively) & also superior to olopatadine 0.2% (p=0.0009) for OI after 24 hours at all 3 post-CAC time points (avg. treatment difference was -0.31). The pooled analysis of safety parameters showed no discernable trends or clinically relevant differences across the treatment groups; a review of adverse events did not reveal any safety issues for HDO. No deaths or treatment-emergent serious AEs were reported in these studies.

 
Conclusions
 

This analysis strengthens conclusions drawn from 2 studies that olopatadine 0.77% was superior to vehicle at onset and after 24 hours, as well as superior to olopatadine 0.2% at 24 hours after dosing with respect to reduction of OI associated with AC. Olopatadine 0.77% had a safety profile comparable to olopatadine 0.2%.

 
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