RESUMEN
SIGNIFICANCE: There is a clinical necessity for dry eye disease treatments that perform across a broad range of presenting patient severities. Varenicline solution nasal spray (VNS), a unique cholinergic agonist ocular surface-sparing nasal spray therapy, demonstrated significant improvement in both signs and symptoms of dry eye disease in subjects with mild, moderate, and severe symptoms as the clinical studies enrolled a more real-world patient population. PURPOSE: This study evaluated efficacy outcomes for VNS in patients with mild-moderate and severe dry eye disease. METHODS: An analysis of integrated data from two randomized clinical trials, ONSET-1 (NCT03636061) and ONSET-2 (NCT04036292) (vehicle control [VC], n = 294; VNS 0.03 mg, n = 308), was performed. Adults 22 years or older with dry eye disease, Ocular Surface Disease Index score of ≥23, corneal fluorescein staining score of ≥2 in ≥1 regions/≥4 all regions, and Schirmer Test Score (STS) of ≤10 mm (no restrictions on Eye Dryness Score [EDS]) were included in this study. Efficacy was evaluated using analysis of covariance among pre-specified subgroups of mild-moderate and severe baseline disease severity defined by STS (≤5 vs. >5) and EDS (<60 vs. ≥60). Consistency of effect was evaluated by interaction tests. RESULTS: No treatment-subgroup interactions were observed for all end points ( P > .05). The odds of achieving a ≥10-mm improvement in STS for VNS versus VC for patients with baseline STS ≤5 and >5 were 3.4(95% confidence interval, 2.0 to 5.6) and 2.3(1.3 to 4.0) and for EDS of <60 and ≥60 were 3.4(1.9 to 6.1) and 2.5(1.5 to 4.0). Least-squares mean treatment/VC differences in change from baseline in EDS for patients with baseline STS ≤5 or >5 were -7.4(95% confidence interval, -12.5 to -2.4) and -2.8(-8.7 to 3.1); EDS of <60 and ≥60 were -2.9(-8.3 to 2.5) and -8.1(-13.6 to -2.6). CONCLUSIONS: Compared with VC, VNS improved tear production and patient-reported symptoms in patients with dry eye disease, demonstrating consistency of effect regardless of initial presenting severity.
Asunto(s)
Síndromes de Ojo Seco , Rociadores Nasales , Adulto , Humanos , Síndromes de Ojo Seco/tratamiento farmacológico , Soluciones Oftálmicas , Gravedad del Paciente , Lágrimas , Resultado del Tratamiento , Vareniclina/uso terapéuticoRESUMEN
In this report the use of eye cosmetic products and procedures and how this represents a lifestyle challenge that may exacerbate or promote the development of ocular surface and adnexal disease is discussed. Multiple aspects of eye cosmetics are addressed, including their history and market value, psychological and social impacts, possible problems associated with cosmetic ingredients, products, and procedures, and regulations for eye cosmetic use. In addition, a systematic review that critically appraises randomized controlled trial evidence concerning the ocular effects of eyelash growth products is included. The findings of this systematic review highlight the evidence gaps and indicate future directions for research to focus on ocular surface outcomes associated with eyelash growth products.
Asunto(s)
Cosméticos , Oftalmopatías , Humanos , Ojo , Oftalmopatías/etiología , Cosméticos/efectos adversos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Purpose: To evaluate the impact of Demodex blepharitis on patients' daily activities and quality of life. Patients and Methods: In this multicenter, observational, prospective, IRB-approved study, 311 Demodex blepharitis patients aged ≥18 years were included. Demodex blepharitis was diagnosed based on the presence of ≥1.0 mite per lash (upper and lower eyelids combined), >10 collarettes on the upper lashes, and at least mild lid margin erythema of the upper eyelid in at least one eye. All patients were asked to complete a questionnaire about their symptoms, daily activities, quality of life, and management approaches, and descriptive statistics were used to analyze the responses. Results: More than half the patients had been experiencing symptoms of blepharitis for ≥4 years. The three most frequent and bothersome symptoms experienced by patients were dry eyes, itchiness, and irritation. Nearly half the patients (47%) responded that they were conscious of their eyes all day, and 23% said that they were constantly worrying about their eyes. Other activities that were negatively affected included difficulty driving at night (47%), additional time needed for daily hygiene routine (30%), and difficulty in wearing eye make-up (in 34% of females). While all subjects had objective signs of Demodex blepharitis confirmed by an eye care provider, 58% said they had never previously been diagnosed with blepharitis. The most commonly used management approaches for Demodex blepharitis were artificial tears (47%), warm compresses (32%), and lid wipes (14%). Conclusion: Demodex blepharitis has a significant negative impact on daily activities and the mental and physical well-being of afflicted patients.
RESUMEN
PURPOSE: To evaluate the effect of a single vectored thermal pulsation (VTP) treatment in contact lens wearers with meibomian gland dysfunction (MGD) and dry eye symptoms. METHODS: The prospective, nonsignificant risk, open-label, randomized, multi-center clinical trial included 55 soft contact lens (SCL) wearers with MGD and evaporative dry eye. Subjects were randomized to the single VTP treatment group or an untreated control. The controls received a crossover VTP treatment at 3 months (crossover treatment group). Primary effectiveness measures were meibomian gland secretion (MGS) score and Standard Patient Evaluation of Eye Dryness (SPEED) that were evaluated at baseline, at 1 and 3 months post-VTP treatment, and at 1 month post-VTP treatment in the crossover treatment group. Exploratory variables included fluorescein tear break-up time (TBUT), lid wiper epitheliopathy (LWE), lid parallel conjunctival folds (LIPCOF), ocular surface staining, frequency of over-the-counter (OTC) drop use, and hours of comfortable contact lens wear. RESULTS: At 3 months, the treatment group showed significantly greater mean change from baseline in MGS (12.4±9.1 vs 1.4±6.4, p<0.0001), SPEED (-8.4±4.7 vs -0.7±4.4, p<0.0001) and significantly greater improvement in exploratory variables (TBUT, LWE, and frequency of OTC drop use) relative to the controls. Mean comfortable contact lens wearing time increased by 4.0±3.9 hours at 1 month. This was sustained for 3 months with no change in the control group. The crossover treatment group demonstrated similar results to the treatment group at 1 month post-VTP. CONCLUSION: In SCL wearers with MGD, a single VTP treatment significantly improved mean meibomian gland function and significantly reduced dry eye signs and symptoms compared to an untreated control. The treatment increased mean comfortable lens wearing time by 4 hours (approximately doubling the pretreatment findings). This was sustained for up to 3 months post-treatment on average.