Ophthalmic Formulations for the Treatment of Allergic Conjunctivitis and Their Effect on the Ocular Surface: A Review of Safety and Tolerability Assessments in Clinical Trials.

Allergic conjunctivitis (AC) is the most common allergic eye disorder. Antiallergic eyedrops are the first line of pharmacological treatment. However, the application of antiallergic eyedrops can potentially alter tear homeostasis and affect the ocular surface, which may result in iatrogenic diseases such as dye eye disease (DED). Long-term treatment of AC with eyedrops containing preservatives and other components may increase the risk of DED and ocular surface damage. Here, we examined 20 clinical trials published during the past ten years with antihistamine ophthalmic formulations in the treatment of AC, to evaluate the extent of evidence about their safety and tolerability. Remarkably, we find that most trials lack an evaluation of the critical ocular surface parameters, such as tear film break-up time, tear volume, corneal and conjunctival damage, and inflammation, to properly assess the state of the ocular surface state after prolonged treatment. There is a need to increase awareness of the use of specific formulations that do not increase the risk of iatrogenic DED.