PMU135 PATIENT-REPORTED OUTCOME MEASURES IN PATIENTS WITH CHRONIC OCULAR SURFACE PAIN : A LITERATURE REVIEW

Abstract

Chronic ocular surface pain (COSP) is a persistent eye pain at the ocular surface lasting for a period longer than 3 months that interferes with regular daily activities, and is severely impacting patients’ health related quality of life (HRQoL).The aim of this study was to review the suitability of existing patient-reported outcome measures (PROMs) for use in clinical trials, assessing potential new therapies of COSP. Literature searches were performed in Medline and Embase using Ovid SP platform until March 2019. Specific search terms were used to identify studies assessing QoL in patients experiencing ocular pain. The review was complemented by searching relevant trials using PRO endpoints in ocular pain on clinicaltrials.gov. The measurement characteristics of the identified tools were reviewed in line with FDA’s 2009 PRO Guidance. A total of 1,130 abstracts were identified for initial screening and 177 were selected for full text review. In total 16 tools were identified, and of these, only four (Ocular Pain Assessment Survey (OPAS), Eye Sensation Scale (ESS), Neuropathic Pain Symptom Inventory (NPSI)-Eye and Brief Ocular Discomfort Inventory (BODI) specifically measured ocular pain. OPAS and ESS were originally developed for measuring ocular pain, whereas NPSI-Eye and BODI are modified versions of generic pain scales. As OPAS assesses the most critical HRQoL impacts of COSP such as impact on visual functioning, mood, sleep in addition to severity and type of pain assessment, it appears being the most adequate tool for its usage in future clinical trials. Among the PROMs identified for usage in future COSP clinical trials, OPAS appears to be the most suitable one. Further investigation is needed to ensure that OPAS is an appropriate and well-validated tool to assess new treatments for COSP in accordance with regulatory requirements.