Display options
Cite
McLaurin E, Bergmann M, Narvekar A, et al. Pooled analysis of two studies evaluating efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis. Clin Ophthalmol. 2017;11:1089-1097doi: 10.2147/OPTH.S131830.
McLaurin, E., Bergmann, M., Narvekar, A., Adewale, A., Gomes, P., & Torkildsen, G. (2017). Pooled analysis of two studies evaluating efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis. Clinical ophthalmology (Auckland, N.Z.), 111089-1097. https://doi.org/10.2147/OPTH.S131830
McLaurin, Eugene, et al. "Pooled analysis of two studies evaluating efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis." Clinical ophthalmology (Auckland, N.Z.) vol. 11 (2017): 1089-1097. doi: https://doi.org/10.2147/OPTH.S131830
McLaurin E, Bergmann M, Narvekar A, Adewale A, Gomes P, Torkildsen G. Pooled analysis of two studies evaluating efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis. Clin Ophthalmol. 2017 Jun 08;11:1089-1097. doi: 10.2147/OPTH.S131830. eCollection 2017. PMID: 28652694; PMCID: PMC5472412.
Copy Download .nbib Format: NLM
Share it on

Clin Ophthalmol. 2017 Jun 08;11:1089-1097. doi: 10.2147/OPTH.S131830. eCollection 2017.

Pooled analysis of two studies evaluating efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis.

Clinical ophthalmology (Auckland, N.Z.)

Eugene McLaurin, Mark Bergmann, Abhijit Narvekar, Adeniyi Adewale, Paul Gomes, Gail Torkildsen

Affiliations

  1. Department of Ophthalmology, Total Eye Care, PA, Memphis, TN.
  2. Department of Ophthalmology, Apex Eye, Cincinnati, OH.
  3. Department of Ophthalmology, Alcon Research Ltd, Fort Worth, TX.
  4. Department of Ophthalmology, Ora Inc.
  5. Department of Ophthalmology, Andover Eye Associates, Andover, MA, USA.

PMID: 28652694 PMCID: PMC5472412 DOI: 10.2147/OPTH.S131830

Abstract

PURPOSE: Two individual phase 3 conjunctival allergen challenge (CAC) studies of similar design have assessed the efficacy and safety of olopatadine hydrochloride (HCl) 0.77% for the treatment of allergic conjunctivitis. The purpose of this study is to evaluate the integrated efficacy and safety of olopatadine HCl 0.77% from a larger dataset by pooling data from the two individual CAC studies.

METHODS: Data were pooled from two phase 3, randomized, multicenter, double-masked, active- and vehicle-controlled CAC studies. The primary comparison was on ocular itching scores between olopatadine HCl 0.77% versus vehicle (at onset and 24 hours) and olopatadine HCl 0.77% versus olopatadine 0.2% (at 24 hours). Additional end points included conjunctival redness, total redness, and proportion of itching responders at onset and 24-hour duration of CAC. For both primary and secondary analysis, mixed model repeated measures analysis was used, except for proportion of ocular itching responders. Sensitivity analyses were carried out using a two-sample

RESULTS: This analysis included 448 patients. Olopatadine HCl 0.77% was superior to vehicle (

CONCLUSION: This analysis confirms the findings from the individual studies. The rapid onset and prolonged duration of action (for 24 hours) of olopatadine HCl 0.77% supports once-daily dosing in the treatment of allergic conjunctivitis.

Keywords: allergic conjunctivitis; conjunctival allergen challenge; conjunctival redness; ocular itching; olopatadine

Conflict of interest statement

Disclosure Eugene McLaurin has received research grants from the following companies: Aciex, Acucela, Alcon Research Ltd., Allergan, AstraZeneca, Bausch & Lomb, Inotek Pharma, InSite Vision, Lexicon P

References

  1. Clin Ther. 2000 Jul;22(7):826-33 - PubMed
  2. Cornea. 2015 Oct;34(10):1245-51 - PubMed
  3. Clin Ophthalmol. 2008 Sep;2(3):525-31 - PubMed
  4. J Pharmacol Exp Ther. 1996 Sep;278(3):1252-61 - PubMed
  5. J Allergy Clin Immunol. 2010 Oct;126(4):778-783.e6 - PubMed
  6. Arch Ophthalmol. 1990 Jan;108(1):84-8 - PubMed
  7. Curr Opin Allergy Clin Immunol. 2011 Oct;11(5):471-6 - PubMed
  8. J Ocul Pharmacol Ther. 1996 Winter;12(4):389-400 - PubMed
  9. Allergy Asthma Proc. 2004 Jan-Feb;25(1):69-75 - PubMed
  10. Clin Ophthalmol. 2015 Sep 14;9:1703-13 - PubMed
  11. Expert Opin Drug Metab Toxicol. 2008 Apr;4(4):453-61 - PubMed
  12. Curr Med Res Opin. 2007 Jun;23(6):1445-52 - PubMed
  13. Clin Ophthalmol. 2011 Jan 13;5:87-93 - PubMed
  14. Int Ophthalmol. 2004 May;25(3):171-9 - PubMed
  15. J Ocul Pharmacol Ther. 2015 May;31(4):204-10 - PubMed
  16. Clin Ther. 2004 Aug;26(8):1237-48 - PubMed
  17. Arch Ophthalmol. 1999 May;117(5):643-7 - PubMed
  18. J Asthma Allergy. 2013 Apr 08;6:43-52 - PubMed
  19. Clin Ther. 2001 Aug;23(8):1272-80 - PubMed

Publication Types