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

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 t-test.

Results

This analysis included 448 patients. Olopatadine HCl 0.77% was superior to vehicle (P<0.0001) at onset and 24-hour duration of action (difference in means: −1.14 to −1.52) and to olopatadine 0.2% (P=0.0009) at 24-hour duration of action in relieving ocular itch. Additionally, olopatadine HCl 0.77% substantially reduced conjunctival redness and total redness over vehicle and olopatadine 0.2% at onset and 24-hour duration of action. At 24 hours CAC, there were a higher proportion of itching responders with olopatadine HCl 0.77% compared to vehicle or olopatadine 0.2% (difference in proportion of responders: 43.17%, P<0.0001, and 17.25%, P=0.0012, respectively). No safety concerns were identified.

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:

• olopatadine
• allergic conjunctivitis
• conjunctival allergen challenge
• ocular itching
• conjunctival redness

Acknowledgments

This study was sponsored by Novartis Pharmaceutical Corporation (Fort Worth, TX, USA). Novartis Pharmaceutical Corporation participated in the design of the studies, analysis of the data, and approval of the manuscript. In addition, Ora Inc. provided support with the design and conduct of the studies. Alcon Research sponsored this study. Medical writing and editorial assistance was given by Rhutika Desai and Usha Gutti (Scientific Services Practice-Product Lifecycle Service, Novartis Healthcare Pvt. Ltd., Hyderabad, India) toward the development of this manuscript.

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 Pharma, Mimetogen, and Ocular Therapeutix. Mark Bergmann is a study investigator; he has received consultancy fees from Ora, Inc. Abhijit Narvekar was a former employee, and Adeniyi Adewale is an employee of Alcon Research Ltd. Paul Gomes is the vice president of Allergy and an employee at Ora, Inc., an organization that consults and conducts research and clinical trials in the field of ocular allergy and other areas of ophthalmology and allergic diseases. Gail Torkildsen is a study investigator; she has received consultancy fees from Ora, Inc., reimbursement of meeting traveling expenses from Alcon Research Ltd., and research grants from Allergan. The authors report no other conflicts of interest in this work.