Effects of a new formulation of olopatadine ophthalmic solution on nasal symptoms relative to placebo in two studies involving subjects with allergic conjunctivitis or rhinoconjunctivitis

• DOI: 10.1185/030079905x43622
• Publication Date: 2005-08-16T09:40:24Z
• Authors: Mark B. Abelson; Paul J. Gomes; Cullen T. Vogelson; Terri A. Pasquine; F. Darell Turner; David T. Wells; Stella M. Robertson
• Keywords: Allergic conjunctivitis

Background: A new formulation of olopatadine hydrochloride ophthalmic solution (olopatadine 0.2%) was evaluated in two separate, randomized, placebo-controlled, double-masked, hybrid environmental studies intended to determine efficacy and safety subjects with histories seasonal allergic conjunctivitis or rhinoconjunctivitis.Design methods: In these 10- 12-week trials (conducted April–August 2003 July–December 2001, respectively), assessed their ocular signs symptoms. Additionally, the 10-week trial frequency nasal symptoms while both severity The had a combined enrollment 500 (217 males, 283 females) including 44 children aged 10–17 years; population 81.4% Caucasian, 9.2% Black, 2% Hispanic, 7.4% other. Daily throughout studies, either ragweed (fall study) grass (spring pollen counts were obtained from each investigative center. Slope analyses conducted on symptom assessments by count.Results: results clinical are presented herein. fall study, relative placebo, 0.2% significantly reduced effects sneezing (p = 0.0355) itchy nose 0.0032), 0.0451), 0.0178), runny 0.0327). spring 0.0017) 0.0031) placebo. trial, 2 discontinued due treatment-related adverse events (tachycardia dry eye), no subject event. No study suffered serious event.Conclusions: For enrolled appeared be safe, well-tolerated, effective reducing and/or some