SAFETY AND EFFICACY OF A TOPICAL COMBINATION OF PHENYLEPHRINE AND NAPHAZOLINE FOR MANAGEMENT OF OCULAR REDNESS: PHASE IV CLINICAL STUDY

Dr. Mayuresh Kiran*, Sharvari Lotankar and Lalit Pawaskar

ABSTRACT

Introduction- Red eye is the cardinal sign of ocular inflammation and one of the most common ophthalmologic conditions in the primary care setting. Inflammation of almost any part of the eye, including the lacrimal glands and eyelids, or faulty tear film can lead to red eye. Primary care physicians often effectively manage red eye, although knowing when to refer patients to an ophthalmologist is crucial. A combination of Phenylephrine which is selective, potent, alpha 1 adrenergic receptor agonist has capillary decongestant action in the eye and Naphazoline which is an imidazoline derivative, is an alpha (2)-adrenergic agonist, gives vasoconstrictive and decongestive properties in the eye. This Phase IV study trial evaluates the efficacy and safety of the combination of Phenylephrine and Naphazoline for the treatment of Allergic Rhinitis or Allergic Asthma. Methodology -Total 140 patients were recruited for the study, of which 124 patients completed the study trial and 16 patients were lost to follow up. Assessment of the efficacy was made by the reduction in TSS and four point Likert-type scales. Safety assessment was done by analyzing the adverse events during the trial. Results- The reduction in TSS from 4.2 (baseline) to 2.008 (day 3) and 0.702 (day 5) was observed. 12 episodes of adverse events occurred and reported which were of mild intensity. Conclusion- A combination of Phenylephrine and Naphazoline is safe and effective in the treatment of Ocular Redness.

Keywords: Phenylephrine, Naphazoline, Ocular Redness.