Placebo–Controlled Evaluation of Diquafosol in a Controlled Adverse Environment(CAE)

Abstract

Abstract: : Purpose:To evaluate dry eye patient response using methodology that standardizes environmental conditions such as humidity (<10%RH), temperature (76+–6F), airflow (constant, non–turbulent), and visual tasking (watching a movie) for 60–90 minutes. Methods: We conducted a 4–week, double–blind comparison of 2% diquafosol and placebo in 222 patients with dry eye disease utilizing the CAE. Eligible patients entered a 1–week placebo run–in period, and were evaluated before and after CAE exposure. Patients who qualified by having increased staining and symptoms after the CAE received 4 weeks of treatment and were again evaluated before and after CAE exposure at 4 weeks. Ocular surface staining was evaluated before and after CAE; symptoms were assessed during CAE. Results: Differences between diquafosol treated patients and placebo patients for ocular surface staining (inferior region primary endpoint) for all Dry Eyes are shown in the following table. Differences Between Diquafosol and Placebo for Ocular Surface Staining – Week 4 (Negative values favor diquafosol) 

*P–value < 0.050 The percent of subjects having ocular staining scores of 0 (clear) at week 4 was also significantly higher in the diquafosol treated patients than in the placebo treated patients. The greatest protective effect of diquafosol on symptom exacerbation occurred in a subset of patients with the greatest exacerbation of ocular staining. Conclusions: Diquafosol was more effective than placebo in this study. The use of a CAE allows for evaluation of subjects both prior to and following acute exacerbation and therefore allows for a more complete assessment of drug efficacy.

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • cornea: clinical science • pharmacology