), the industry leader in electronic patient reported outcomes (ePRO) solutions and services for global clinical research, today announced that its eDiary solution, DiaryPRO®, captured some of the primary efficacy data that supported the recent U.S. Food and Drug Administration’s (FDA) approval of Alcon’s Patanase(Olopatadine Hydrochloride) Nasal Spray, indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

For Alcon’s Phase III program, invivodata designed and implemented an eDiary solution that complied with the FDA’s guidance on the use of patient reported outcomes (PROs) in clinical research. During a two-week trial, subjects with seasonal allergic rhinitis used DiaryPRO twice daily to record the frequency and severity of their nasal symptoms. The data captured on DiaryPRO helped Alcon demonstrate a significantly greater decrease in allergy symptoms among patients using Patanase compared with patients using a placebo nasal spray.

&ldquo'In studying Patanase for the relief of allergy symptoms, we needed an efficient and specific data collection method that was easy for patients and investigative site personnel to use,” said G. Michael Wall,  senior director of pharmaceutical product development at Alcon. “invivodata met our tight enrollment timelines and delivered the scientific expertise and technology that were important to the success of this program.”

“This trial represents a common challenge in clinical research: getting the right data from patients at the right time,” said Doug Engfer, president and chief executive officer of invivodata. “We are thrilled to have worked with Alcon in its development of Patanase and support its efforts to provide much needed relief to the millions of patients suffering with allergic rhinitis.”

News

invivodata’s DiaryPRO captures primary efficacy data for Patanase, and Alcon receives FDA approval to market Patanase in the United States.