Efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis using a conjunctival allergen-challenge model

Abstract

Background

Symptom relief for the duration of 24 hours after treatment would benefit patients with allergic conjunctivitis.

Objective

To compare the safety and efficacy of olopatadine 0.77% with vehicle or olopatadine 0.2% in patients with allergic conjunctivitis in a conjunctival allergen-challenge clinical study.

Patients and methods

In this Phase III, multicenter, double-masked, parallel-group, randomized trial, patients with allergic conjunctivitis received olopatadine 0.77%, its vehicle, or olopatadine 0.2%, administered once at visits 3A (day 0), 4A (day 14 ±2), and 5 (day 21 +3). Allergic conjunctivitis-associated sign and symptom assessments included ocular itching, conjunctival redness, total redness, chemosis, and tearing scores. Adverse events and ocular safety parameters were also assessed.

Results

A total of 202 qualifying patients were randomized. Olopatadine 0.77% was superior (P<0.001) to vehicle for treatment of ocular itching at 3, 5, and 7 minutes postchallenge at onset of action and 16- and 24-hour duration of action. Conjunctival redness mean scores were significantly lower for olopatadine 0.77% versus vehicle at all three post-conjunctival allergen-challenge time points: onset (−1.52 to −1.48; P<0.001), 16 hours (−1.50 to −1.38; P<0.01), and 24 hours (−1.58 to −1.38; P<0.05). At 24 hours, olopatadine 0.77% was superior to olopatadine 0.2% at all three postchallenge time points for ocular itching (P<0.05), conjunctival redness (P<0.05), and total redness (P<0.05). No clinically relevant differences in safety parameters or adverse events were observed between the treatment groups.

Conclusion

Olopatadine 0.77% is superior to both its vehicle and olopatadine 0.2% for the treatment of allergen-mediated ocular itching and conjunctival redness. Ocular itching symptom relief is maintained over 24 hours, supporting once-daily dosing and demonstrating a comparable safety profile to olopatadine 0.2%.

Keywords:

• allergic conjunctivitis
• allergic rhinoconjunctivitis
• ocular inflammation
• antihistamine
• conjunctival allergen-challenge (CAC) model
• high-concentration olopatadine

Acknowledgments

Alcon Research Ltd (Fort Worth, TX) participated in the design of the study, analysis of the data, and approval of the manuscript. Adeniyi Adewale, of Alcon Research, confrmed the accuracy of the data and data analysis. In addition, Ora Inc provided support with the design and conduct of the study. This study was sponsored by Alcon Research. Medical writing support, which was funded by Alcon Research, was provided by Silvia Grisendi, of DJE Science. A subset of the results of this paper were presented at the American Academy of Allergy, Asthma & Immunology Meeting 2014 in San Diego, CA, as a poster presentation with interim findings. The poster’s abstract was published as an online supplement to the Journal of Allergy and Clinical Immunology, and can be accessed on the journal’s website – http://www.jacionline.org. The actual paper, however, has never been published.

Author contributions

All authors actively contributed to the development of this article through participation in the research and preparation of the manuscript. Also, all authors reviewed and approved the final version. AN had full access to all the data in the study, and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Disclosure

GT (study investigator) received consultancy fees from Ora Inc and reimbursement of traveling expenses from Alcon Research. AN (clinical trial manager) is an employee of Alcon Research. MB (study investigator) reports no conflicts of interest in this work. The authors report no other conflicts of interest in this work.