Understanding Perspectives on Presbyopia and Use of Pilocarpine HCl 1.25% Twice Daily from Participants of the Phase 3 VIRGO Study.

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.

Impact of presbyopia treatment pilocarpine hydrochloride 1.25% on night-driving performance.

CLINICAL RELEVANCE: Patients prescribed pilocarpine ophthalmic solution are advised to be cautious when driving at night, but studies evaluating the effects of pilocarpine hydrochloride ophthalmic solution 1.25% (pilo), approved to treat presbyopia, on driving at night are lacking. BACKGROUND: This double-masked, crossover, phase 3b study evaluated night-driving performance with pilo or the placebo once daily. METHODS: Forty-three adults (40-55 years) with presbyopia impacting daily activities and mesopic, high-contrast, binocular distance-corrected near vision 6/12-6/30 were randomised to bilateral treatment with pilo followed by placebo or placebo followed by pilo (with a ≥7-day washout between interventions). Night-driving performance was evaluated at twilight at a closed-circuit course. Primary efficacy endpoint: overall composite night-driving performance Z score at the end of the 7-14-day intervention period, 1 hour post-instillation. Pilo was considered non-inferior if the lower limit of the 95% confidence interval (CI) for the least squares mean difference (LSMD, pilo minus placebo) was >-0.25. Other efficacy endpoints: individual components of the night-driving performance test (hazard avoidance rate; road sign recognition rate and distance; pedestrians recognition distance; overall driving and lane-keeping times) and night-driving experience questionnaire. Safety included treatment-emergent adverse events (TEAEs). RESULTS: The mean overall composite Z scores were -0.121 (pilo) and 0.118 (placebo). The LSMD (pilo minus placebo) was -0.224 (95% CI, -0.346, -0.103), with 3 of the 7 individual tasks being significantly better with the placebo. The questionnaire did not reveal significant differences between pilo and the placebo. There were no serious or severe TEAEs and no TEAE-related discontinuations. The most common ocular TEAEs were headache and visual impairment with pilo (both 27.9%), and dry eye (7.0%) with the placebo. CONCLUSION: The overall performance of night driving was inferior with pilo, compared with placebo. The study findings are consistent with the current class labelling and provide evidence to inform regulators and assist clinicians considering prescribing pilo to adults who seek treatment of presbyopia symptoms and drive at night.ClinicalTrials.gov identifier: NCT04837482.

The Prevalence of Demodex Blepharitis in US Eye Care Clinic Patients as Determined by Collarettes: A Pathognomonic Sign.

Purpose: To evaluate the prevalence of Demodex blepharitis by its pathognomonic sign, collarettes, in patients presenting for any reason to eye care clinics in the United States. Patients and Methods: In this retrospective study by 7 investigators at 6 eye care clinics, case records of consecutive patients who underwent a slit-lamp examination, regardless of chief complaint, were reviewed for Demodex blepharitis, as identified by the presence of collarettes. Patient characteristics, including age, gender, race, relevant ocular and systemic diagnoses, ocular medications, lid hygiene practices and contact lens wear, were also recorded. Results: Of 1032 patients (mean age: 60.2 ± 17.8 years), 57.7% had Demodex blepharitis. While the prevalence of Demodex blepharitis in patients with dry eye disease (DED) (58.9%) and cataract (55.7%) was similar to the overall prevalence of Demodex blepharitis, it was higher in patients with blepharitis (69.1%) and glaucoma (64.8%). Among patients with collarettes, 44.0% had never been diagnosed with blepharitis. Among those on anti-inflammatory DED treatment, 60.0% had Demodex blepharitis. Demodex blepharitis prevalence was significantly higher among those using topical tea tree oil versus those who were not (74.5% versus 56.7% p = 0.014); prevalence was comparable among those using/not using lid wipes (56.9% versus 55.5%). Conclusion: Demodex blepharitis, based on the pathognomonic finding of collarettes, is common and likely underdiagnosed among patients seeking eye care. These collarettes are still found in patients using over-the-counter treatments for blepharitis. The present study highlights the importance of screening patients for collarettes and Demodex blepharitis as part of every slit-lamp examination.

The Relationship Between Dry Eye Disease and Digital Screen Use.

Dry eye disease is characterized by tear film instability that can result in ocular surface damage. Patients with dry eye disease may experience ocular pain/discomfort and visual disturbances that may negatively impact quality of life. Increased use of digital screens for work, communication, and entertainment, especially during times of pandemic, may contribute to dry eye. Extensive cross-sectional studies have shown that digital screen use duration is associated with an increased risk of severe symptoms and clinical diagnosis of dry eye disease in adults. Smartphone use duration has also been found to be greater in school-age children with dry eye disease than in those without dry eye disease. A commonly accepted hypothesis for the relationship between digital screen use and dry eye disease is that digital screen use changes blinking dynamics, leading to ocular dryness. This review describes evidence that digital screen use is associated with dry eye disease, that digital device use alters blinking dynamics, and that dry eye affects mental health and work productivity in digital screen users. Helpful prevention and management strategies for dry eye disease exist for those who use digital screens.

Demodex.

PURPOSE: Demodex folliculorum and Demodex brevis are ectoparasites with an astounding prevalence of 100% in patients aged 70 years and older. Every person in this age group is estimated to carry a colony of 1000 to 2000 mites. With such a high prevalence, little attention has been paid to the mite among eye care practitioners. We demonstrate a clinical sequence in a set of case reports to identify the mite. The clinical sequence includes a clinical history of blepharitis, dry eyes, and/or ocular allergy; slit lamp examination of cylindrical dandruff; and confirmation using light microscope evaluation of epilated lashes. CASE REPORTS: Patient 1 was a 68-year-old woman who demonstrates associations with dry eyes and diabetes. Patient 2 was a 44-year-old man with uncommonly seen D. brevis present. Patient 3 was a 40-year-old woman with dry eyes and allergy, showing mite tails protruding from base of lashes. Patient 4 was a 60-year-old woman who demonstrates the association with rosacea. Patient 5 was a 53-year-old woman intermittently taking topical steroid and antibiotic combination medications, with an actual mite photographed on the surface. CONCLUSIONS: Following a clinical sequence helps identify Demodex, the underdiagnosed, undertreated, and underappreciated ocular surface disease.