Milton M Hom, Omar Ladhani, Zuoyi Zhang, Haixia Liu, Sadhana Sonparote, Charlotte C Dancey
{"title":"ABBV-444的患者体验，一项含有海藻糖和透明质酸钠的新型人工泪液治疗干眼症状的概念验证研究。","authors":"Milton M Hom, Omar Ladhani, Zuoyi Zhang, Haixia Liu, Sadhana Sonparote, Charlotte C Dancey","doi":"10.2147/OPTO.S490732","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Dry eye disease (DED) causes discomfort and potential damage to the surface of the eye, commonly managed with artificial tears. We assessed symptom relief, tolerability, and patient experience of a novel carboxymethyl-cellulose-based artificial tear formulation with trehalose and sodium hyaluronate (ABBV-444) in patients with DED.</p><p><strong>Methods: </strong>This open-label, single-arm, single center study enrolled adult patients with baseline Ocular Surface Disease Index (OSDI) scores of ≥18 and ≤65. Patients were instructed to use ABBV-444 as often as needed but at least twice a day for 30 days. The primary endpoint was change from baseline in OSDI score at Day 30. Secondary endpoints were onset of action (change from baseline in current symptom survey [CSS] visual analog scale [VAS] scores over 5 minutes post administration on Day 1) and patients' experience (change from baseline in Patient Eye Drop Experience [PEDE] survey VAS scores at Day 30). Outcomes were assessed in the per-protocol (PP) population using descriptive statistics. A paired <i>t</i>-test was performed to calculate <i>P</i>-values.</p><p><strong>Results: </strong>A total of 34 patients were included in the PP population. DED severity, measured by OSDI, significantly decreased by a mean (standard deviation; SD) score of 6.8 (15.0) points from baseline to Day 30 (<i>P=</i>0.006). Patients showed significant symptom improvement as early as 30 seconds after application, with mean (SD) CSS changes from baseline of -3.3 (10.3) points at 30 seconds (<i>P</i>=0.03) and -10.1 (10.6) points at 5 minutes post-dose (<i>P</i><0.001). No adverse events were reported. PEDE scores averaged between 76.4 (36.7) and 85.7 (21.0) at Day 30.</p><p><strong>Conclusion: </strong>Continuous daily treatment with ABBV-444 reduced DED symptom severity over 30 days and demonstrated rapid onset of action within 30 seconds post administration. These results suggest that ABBV-444 is a viable therapy for DED symptoms and support further investigation of longer-term treatment in multicenter trials.</p>","PeriodicalId":43701,"journal":{"name":"Clinical Optometry","volume":"17 ","pages":"37-45"},"PeriodicalIF":1.4000,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11830937/pdf/","citationCount":"0","resultStr":"{\"title\":\"Patient Experience with ABBV-444, a Proof-of-Concept Study for a Novel Artificial Tear with Trehalose and Sodium Hyaluronate for Dry Eye Symptoms.\",\"authors\":\"Milton M Hom, Omar Ladhani, Zuoyi Zhang, Haixia Liu, Sadhana Sonparote, Charlotte C Dancey\",\"doi\":\"10.2147/OPTO.S490732\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Dry eye disease (DED) causes discomfort and potential damage to the surface of the eye, commonly managed with artificial tears. We assessed symptom relief, tolerability, and patient experience of a novel carboxymethyl-cellulose-based artificial tear formulation with trehalose and sodium hyaluronate (ABBV-444) in patients with DED.</p><p><strong>Methods: </strong>This open-label, single-arm, single center study enrolled adult patients with baseline Ocular Surface Disease Index (OSDI) scores of ≥18 and ≤65. Patients were instructed to use ABBV-444 as often as needed but at least twice a day for 30 days. The primary endpoint was change from baseline in OSDI score at Day 30. Secondary endpoints were onset of action (change from baseline in current symptom survey [CSS] visual analog scale [VAS] scores over 5 minutes post administration on Day 1) and patients' experience (change from baseline in Patient Eye Drop Experience [PEDE] survey VAS scores at Day 30). Outcomes were assessed in the per-protocol (PP) population using descriptive statistics. A paired <i>t</i>-test was performed to calculate <i>P</i>-values.</p><p><strong>Results: </strong>A total of 34 patients were included in the PP population. DED severity, measured by OSDI, significantly decreased by a mean (standard deviation; SD) score of 6.8 (15.0) points from baseline to Day 30 (<i>P=</i>0.006). Patients showed significant symptom improvement as early as 30 seconds after application, with mean (SD) CSS changes from baseline of -3.3 (10.3) points at 30 seconds (<i>P</i>=0.03) and -10.1 (10.6) points at 5 minutes post-dose (<i>P</i><0.001). No adverse events were reported. PEDE scores averaged between 76.4 (36.7) and 85.7 (21.0) at Day 30.</p><p><strong>Conclusion: </strong>Continuous daily treatment with ABBV-444 reduced DED symptom severity over 30 days and demonstrated rapid onset of action within 30 seconds post administration. These results suggest that ABBV-444 is a viable therapy for DED symptoms and support further investigation of longer-term treatment in multicenter trials.</p>\",\"PeriodicalId\":43701,\"journal\":{\"name\":\"Clinical Optometry\",\"volume\":\"17 \",\"pages\":\"37-45\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2025-02-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11830937/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Optometry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/OPTO.S490732\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Optometry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/OPTO.S490732","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
Patient Experience with ABBV-444, a Proof-of-Concept Study for a Novel Artificial Tear with Trehalose and Sodium Hyaluronate for Dry Eye Symptoms.
Purpose: Dry eye disease (DED) causes discomfort and potential damage to the surface of the eye, commonly managed with artificial tears. We assessed symptom relief, tolerability, and patient experience of a novel carboxymethyl-cellulose-based artificial tear formulation with trehalose and sodium hyaluronate (ABBV-444) in patients with DED.
Methods: This open-label, single-arm, single center study enrolled adult patients with baseline Ocular Surface Disease Index (OSDI) scores of ≥18 and ≤65. Patients were instructed to use ABBV-444 as often as needed but at least twice a day for 30 days. The primary endpoint was change from baseline in OSDI score at Day 30. Secondary endpoints were onset of action (change from baseline in current symptom survey [CSS] visual analog scale [VAS] scores over 5 minutes post administration on Day 1) and patients' experience (change from baseline in Patient Eye Drop Experience [PEDE] survey VAS scores at Day 30). Outcomes were assessed in the per-protocol (PP) population using descriptive statistics. A paired t-test was performed to calculate P-values.
Results: A total of 34 patients were included in the PP population. DED severity, measured by OSDI, significantly decreased by a mean (standard deviation; SD) score of 6.8 (15.0) points from baseline to Day 30 (P=0.006). Patients showed significant symptom improvement as early as 30 seconds after application, with mean (SD) CSS changes from baseline of -3.3 (10.3) points at 30 seconds (P=0.03) and -10.1 (10.6) points at 5 minutes post-dose (P<0.001). No adverse events were reported. PEDE scores averaged between 76.4 (36.7) and 85.7 (21.0) at Day 30.
Conclusion: Continuous daily treatment with ABBV-444 reduced DED symptom severity over 30 days and demonstrated rapid onset of action within 30 seconds post administration. These results suggest that ABBV-444 is a viable therapy for DED symptoms and support further investigation of longer-term treatment in multicenter trials.
期刊介绍：
Clinical Optometry is an international, peer-reviewed, open access journal focusing on clinical optometry. All aspects of patient care are addressed within the journal as well as the practice of optometry including economic and business analyses. Basic and clinical research papers are published that cover all aspects of optics, refraction and its application to the theory and practice of optometry. Specific topics covered in the journal include: Theoretical and applied optics, Delivery of patient care in optometry practice, Refraction and correction of errors, Screening and preventative aspects of eye disease, Extended clinical roles for optometrists including shared care and provision of medications, Teaching and training optometrists, International aspects of optometry, Business practice, Patient adherence, quality of life, satisfaction, Health economic evaluations.
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