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INTRODUCTION: The phase 3, randomized, vehicle-controlled, 14-day VIRGO study evaluated the efficacy and safety of twice-daily dosing of pilocarpine hydrochloride ophthalmic solution 1.25% (Pilo) in presbyopia. On VIRGO exit, a companion study was conducted to assess the patient experience with presbyopia and satisfaction with Pilo. METHODS: Recruited individuals completed the Presbyopia Patient Satisfaction Questionnaire (PPSQ) plus a three-part exit survey, or a live interview. The PPSQ evaluated respondents' experience with Pilo. Survey parts 1 and 2 evaluated experience managing presbyopia before and during VIRGO, respectively; part 3 assessed future possibilities of using Pilo in real-world situations. The interview further informed the interviewees' experience with presbyopia and Pilo. The primary endpoint was responders (%) in each rating category of the PPSQ items 1-7; the secondary endpoints were summary of categorical (survey) and qualitative (interviews) responses. RESULTS: The PPSQ and survey included 62 participants who received Pilo (N = 28) or vehicle (N = 34) in VIRGO; the interview included ten participants (Pilo, N = 4; vehicle, N = 6). Per the PPSQ, 64.3% of Pilo users reported vision improvement, including 17.9% with complete improvement; ≥ 46.4% were satisfied/very satisfied with their ability to perform daily activities, see up close unaided, and read in dim light. Among vehicle users, these percentages were 35.3%, 0%, and ≤ 23.5%, respectively. In both subgroups, ≥ 67.9% were interested in using Pilo or Pilo and eyeglasses/contact lenses in the future. Per the interview, vehicle users (n = 6/6) found the eyedrop easy to use but none experienced meaningful near-vision improvements, stopped using other correction method(s) part of the day, were satisfied with the eyedrop, preferred it over their previous correction method(s), or would continue using it if prescribed. Conversely, 75% (n = 3/4) of Pilo users responded positively to each of these six criteria. CONCLUSIONS: Findings validate the VIRGO results and improve our understanding of the patient experience, demonstrating improved vision and satisfaction with Pilo (vs. vehicle) when performing daily activities.
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BACKGROUND: Managing dry eye disease (DED) is expensive. Often, prescribed treatments improve clinical signs but not patient-reported symptoms. In large surveys, clinicians and patients ranked environmental and behavioral modifications among the most important DED-related research priorities. Our purpose was to investigate the barriers to and facilitators of use of these modifications by patients with DED in the United States and how their use may be impacted by socioeconomic status (SES). METHODS: Using Qualtrics, we conducted an anonymous online survey of adults with DED living in the United States in August to September 2022. Patients were identified through the Dry Eye Foundation, Sjögren's Foundation, and a DED clinic in Colorado. We used an established index for classifying respondent SES based on education, household income, and employment. Outcomes included use of environmental and behavioral modifications and barriers to and facilitators of their use. RESULTS: We included 754 respondents (SES: 382 low, 275 high, and 97 unclear). Most were aged 18 to 49 years (67%), female (68%), and White (76%) and reported dealing with DED for ≤5 years (67%). The most frequent modifications were taking breaks to rest eyes (68%), increasing water intake (68%), and using hot/cold compresses (52%). For these three, the biggest facilitators were as follows: belief that the modification works (27 to 37%), being recommended it (24 to 26%), and ease of use/performance (21 to 32%). Across modifications, the biggest barriers were difficulty of use (55%), lack of family/employer/social/community support (33%), and lack of awareness (32%). The data do not suggest discernible patterns of differences in barriers or facilitators by SES. CONCLUSIONS: Greater emphasis should be placed on explaining to patients how environmental and behavioral modifications might mitigate DED. Employers and members of patients' support systems should be guided regarding how best to support patients in managing DED symptoms.