Epinastine ophthalmic solution earns high marks for comfort, tolerability in comparison study

August 15, 2007

Adult patients with a history of allergic conjunctivitis gave epinastine (Elestat, Inspire Pharmaceuticals and Allergan) high marks for tolerability and comfort in a recent single-center, double-masked, four-visit crossover study.

Key Points

The single-center, double-masked crossover study was undertaken to compare the tolerability, comfort, and acute drying effects of three topical antihistamine/mast-cell stabilizers. Forty patients (12 men, 28 women) with a history of allergic conjunctivitis were enrolled; one left the study after the first visit due to scheduling issues.

"Certainly, drop comfort plays a role in patient compliance. Many patients believe that if the drop stings or is uncomfortable to their eyes, then it is somehow harmful or not helping them. If the drop is more comfortable and soothing, they're more likely to be compliant," said Gail L. Torkildsen, MD, who is in private practice with Andover Eye Associates, Andover, MA. She conducted the study with George W. Ousler III and D. Andrew Workman, director and assistant director of the dry eye department, respectively, at ORA Clinical Research and Development, North Andover, MA, an investigative group specializing in ophthalmology.

Four weekly visits

At the first of four weekly office visits, study enrollees were randomly assigned to receive epinastine in one eye and either azelastine HCl 0.05% ophthalmic solution (Optivar, MedPointe Pharmaceuticals) or ketotifen fumarate 0.25% ophthalmic solution (Zaditor, Novartis) in the fellow eye. An equal number of patients received either azelastine or ketotifen unilaterally.

Participants were asked to rate drop tolerability in both eyes immediately, at 30 seconds, and at 1, 2, and 5 minutes after instillation. Also, they were asked to choose three words to describe drop comfort in both eyes 3 minutes after instillation.

At the second through fourth visits, patients were randomly assigned to receive epinastine, azelastine, or ketotifen in both eyes. Because of the crossover design of the study, all participants had received each of the solutions bilaterally by the end of the study.