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.

Living with presbyopia: experiences from a virtual roundtable dialogue among impacted individuals and healthcare professionals.

BACKGROUND: Presbyopia is a common progressive vision disorder characterised by an inability to focus on near objects. The emergence of newer treatment options in addition to spectacles or contact lenses highlights the importance of assessing patient/user preferences. METHODS: People with presbyopia and healthcare professionals (HCPs) took part in a moderated, structured discussion of specific questions on a virtual advisory-board platform. The objective was to better understand unmet needs and the experience of living with the condition. Closed and open questions were included. RESULTS: Nine individuals (age 40 to 70 years) with presbyopia participated, from Australia, China, France, Italy, Ireland, Japan and the US. One ophthalmologist and one optometrist represented the perspective of HCPs. Over two weeks, 621 posts were entered on the platform. There was widespread agreement that the often stated association between age and presbyopia was unfortunate. Some participants had developed presbyopia at 30-45 years of age. What is more, the association with age was seen as implying a natural process, reducing the incentive to treat. Instead there was a call for an action-oriented view of presbyopia as a condition which may be effectively treated in the future. All participants experienced dealing with presbyopia as burdensome, affecting quality of life to varying degrees. When considering new treatments, convenience was the most important factor. The option to administer drops when needed was considered favourable, but short-acting treatments may not reduce inconvenience compared with spectacles. Participants viewed a therapy that targets the underlying cause of the condition favourably compared with symptomatic treatment. Side effects would severely reduce the appeal of drops. For clinical trials in presbyopia, patient-reported outcomes should be mandatory and need adequately to capture quality of life. Studies in presbyopia must be designed to minimise the inconvenience to participants in order to counter the risk of high drop-out rates. CONCLUSIONS: The interactive format provided insights into living with presbyopia, particularly the negative impact on quality of life, subjects' openness to new therapies, and the need to move away from considering the condition an unavoidable and intractable consequence of ageing.

The term presbyopia describes the difficulty to focus the eyes on things nearby, due to stiffening of the eye lens. The condition often considered something which worsens with increasing age. Many people cope with presbyopia by wearing reading glasses or bifocals, but alternative treatments are being developed. This publication reports from a moderated discussion among people with presbyopia and healthcare professionals specialising in eye health. People with presbyopia strongly felt that it should not be seen as an inevitable effect of middle age, but as something which may be treated medically. They felt that reading glasses, bifocals and monovision lenses were a daily burden and did not fit with how they wanted to live their lives. When discussing possible medical treatments, the option to use drops instead of glasses to improve eye sight appealed to the participants, particularly if the drops acted on the mechanism behind the stiffened lens with effect over many weeks or months. Convenience was the key benefit the participants would look for when considering a new treatment. Importantly, drops must not have any undesirable effects such as burning. The roundtable discussion showed the need for both healthcare professionals and those living with presbyopia to take the condition seriously with an an action-oriented view towards better therapies in the future.

Evaluation of a new artificial tear formulation for the management of tear film stability and visual function in patients with dry eye.

PURPOSE: Artificial tears are the first line of therapy for dry eye disease (DED) and are also the most frequently used treatment approach for this common condition. Despite this, there are few published studies that directly compare the effectiveness of different drop preparations, especially those formulated specifically for dry eye. In this study, we tested a new artificial tear product, Rohto® Dry-Aid™, for its ability to relieve the signs and symptoms of DED. The study used a second drop, Systane® Ultra, as a positive comparator. MATERIALS AND METHODS: This was a prospective, single-center, open-label, parallel-group study comparing the effects of the two products when used continuously over ~30 days (Clinical Trials registration number NCT03183089). Subjects were randomly assigned to one of the two test groups and were monitored 2 and 4 weeks after enrollment. Efficacy endpoints included ocular staining, visual function, and ocular discomfort. RESULTS: Treatment groups had similar ocular staining and ocular comfort scores, and both showed statistically significant ocular discomfort score improvement. Subjects in the Rohto group reported significant improvements in visual tasking activities such as watching television and driving at night. There was also a tendency for diary symptom scores to worsen from morning to evening in the Systane group, but not in the Rohto group; this trend was not significant, but warrants further study. CONCLUSION: The two products, Rohto Dry-Aid and Systane Ultra, elicited comparable effects on the signs and symptoms of DED. While both products are designed to provide long-lasting relief, subjects in the Rohto group experienced a superior relief from discomfort associated with visual tasking activities and daily diaries, indicating that the Rohto drops may provide a longer duration of symptomatic relief over the course of the day.