Evaluation of Eye-Pain Severity between Dry-Eye Subtypes

Yoshikawa, Yamato; Yokoi, Norihiko; Katô, Hiroaki; Sakai, Rieko; Komuro, Aoi; Sonomura, Yukiko; Ikeda, Tsunehiko; Sotozono, Chie

doi:10.3390/diagnostics11020166

Cited by 6 publications

(12 citation statements)

References 30 publications

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“…At day 1, day 15 ± 2, day 29 ± 2, and day 57 ± 2, symptoms were assessed using a visual analog scale (VAS; range, 0-100 points, with 0 = no discomfort and 100 = maximal discomfort), a tool widely used for measuring subjective symptoms for the severity of eye dryness and symptoms (burning/stinging sensation, sticky feeling, foreign body sensation, itching, blurred vision, sensitivity to light, and pain). These symptoms are commonly evaluated in clinical studies of DED . DED severity was also assessed using a valid and reliable instrument, the OSDI questionnaire, consisting of 12 questions (total score range, 0-100, with higher scores representing a worse condition) .…”

Section: Methodsmentioning

confidence: 99%

“…These symptoms are commonly evaluated in clinical studies of DED. 21,[23][24][25] DED severity was also assessed using a valid and reliable instrument, the OSDI questionnaire, consisting of 12 questions (total score range, 0-100, with higher scores representing a worse condition). 26 Signs were assessed by tCFS score using the National Eye Institute scale (range, 0-15, with higher scores representing a worse condition).…”

Section: Clinical Assessmentsmentioning

confidence: 99%

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Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients

et al. 2023

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ImportanceMeibomian gland dysfunction (MGD) is a leading cause of evaporative dry eye disease (DED). Medical and surgical management for DED is limited; therefore, new treatment options are sought.ObjectiveTo evaluate the efficacy and safety of SHR8058 (perfluorohexyloctane) eye drops in Chinese patients with DED associated with MGD through 57 days.Design, Setting, and ParticipantsThis was a randomized, multicenter, double-masked, saline-controlled, phase 3 clinical trial conducted from February 4, 2021, to September 7, 2022. Patients were recruited from the departments of ophthalmology in 15 hospitals in China. Patients with DED associated with MGD were enrolled between February 4 and July 1, 2021. The diagnosis was based on patient complaint of DED symptoms, an ocular surface disease index of 25 or higher, tear film break-up time of 5 seconds or less, Schirmer I test without anesthesia results of 5 mm or more at 5 minutes, total corneal fluorescein staining (tCFS) score of 4 to 11, and an MGD score of 3 or higher.InterventionsEligible participants were randomly assigned 1:1 to receive perfluorohexyloctane eye drops or 0.6% sodium chloride [NaCl]) 4 times per day.Main Outcomes and MeasuresThe primary end points were the changes from baseline in tCFS and eye dryness scores at day 57.ResultsA total of 312 participants were included in the analysis: 156 (mean [SD] age, 45.4 [15.2] years; 118 female [75.6%]) in the perfluorohexyloctane group and 156 (mean [SD] age, 43.7 [15.1] years; 127 female [81.4%]) in the NaCl group. Both primary end points were achieved, ie, changes from baseline at day 57 of tCFS score (mean [SD], −3.8 [2.7] vs −2.7 [2.8]) and eye dryness score (mean [SD], −38.6 [21.9] vs −28.3 [20.8]) in the perfluorohexyloctane group were superior to the control group, with estimated mean differences of −1.14 (95% CI, −1.70 to −0.57; P &lt; .001) and −12.74 (95% CI, −17.20 to −8.28, P &lt; .001), respectively. Improvements on both end points appeared to be noted on day 29 and day 15, respectively, and maintained through day 57. Compared with the control, perfluorohexyloctane eye drops also alleviated symptoms including pain (mean [SD] tCFS score, 26.7 [23.7] vs −18.7 [22.5]; P = .003), awareness of DED symptoms (mean [SD] tCFS score, −38.1 [25.1] vs −23.7 [27.6]; P &lt; .001), and frequency of dryness (mean [SD] tCFS score, −43.3 [23.8] vs −29.1 [24.8]; P &lt; .001). Treatment-emergent adverse events occurred in 34 participants (21.8%) and 40 participants (25.6%) in the perfluorohexyloctane and control groups, respectively.Conclusions and RelevanceResults of this randomized clinical trial demonstrate that perfluorohexyloctane eye drops significantly ameliorated the signs and symptoms of DED associated with MGD with a rapid efficacy as well as satisfactory tolerability and safety through 57 days. Findings support the use of these eye drops if results can be confirmed independently and over longer time periods.Trial RegistrationClinicalTrials.gov Identifier: NCT05515471

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Section: Methodsmentioning

confidence: 99%

Section: Clinical Assessmentsmentioning

confidence: 99%

Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients

et al. 2023

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“…Recently, PainVision ® (PS-2100; Nipro Corporation, Osaka, Japan), a new painless electrical stimulation system for the quantitative assessment of pain intensity via substituting pain with a different sensory stimulation, has been developed and is currently mainly being used in the field of anesthesiology and in pain clinics in Japan [ 13 , 14 , 15 , 16 , 17 , 18 , 19 ]. In a recent study [ 20 ], we used PainVision ® to evaluate EP in DE cases, and we found that the system allowed for easy measurement and assessment of pain and an analysis of its correlation with objective findings. Moreover, we found that the objective finding most significantly associated with EP was the classification of DE subtypes [ 20 ].…”

Section: Introductionmentioning

confidence: 99%

Eye Pain Caused by Epithelial Damage in the Central Cornea in Aqueous-Deficient Dry Eye

Yoshikawa,

Yokoi,

Kusada

et al. 2023

Diagnostics

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In this study, the severity of eye pain (EP) and associated objective findings were evaluated in aqueous-deficient dry eye (ADDE) patients using PainVision®, a quantitative pain-measuring device. This study involved 53 eyes of 53 ADDE patients (6 males and 47 females; mean age: 64.4 ± 13.4 [mean ± SD] years). Of those, 18 eyes of 18 patients underwent punctal occlusion, and EP and objective findings in those patients were evaluated before and after treatment. In all patients, the severity of EP as measured by PainVision® was assessed using the Pain Degree (PD). The median PD for the 53 patients was 30.6 µA/µA (interquartile range, 16.9–93.2), and the nasal and central corneal staining score and the upper lid-wiper epitheliopathy score were significantly correlated with PD (R = 0.33, 0.33, and 0.28, respectively) (all: p < 0.05). Using the least squares method, the central corneal staining score most significantly affected PD. In the 18 cases that underwent punctal occlusion, PD was significantly reduced (median PD: 24.8 to 7.1 µA/µA; p < 0.0001). Using the least squares method, the central corneal staining score and tear meniscus radius were significantly more influential as factors contributing to PD before and after treatment, and central corneal epithelial damage was the factor most associated with ADDE-related EP.

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“…Another important aspect is that, apart from differences in clinical features, the different FBUP types of DED also differ in terms of subjective discomfort of the patient and it is important to know how these aspects correlate each with other. Therefore, analysis of eye pain between dry eye (DE) subtypes using questionnaires and the PainVision ® (Osachi) apparatus was performed [12] and revealed that greater severity of eye pain was found in aqueous-deficient DE and decreased wettability DE than in increased evaporation DE.…”

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confidence: 99%

“…These two studies [11,12] represent a very important clinically applicable development of the FBUPs diagnostic test for DED subgroups and are of immediate interest both for the clinician and for the basic scientist in the field of dry eye and tear film studies.…”

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confidence: 99%