A prospective, multicenter, noninterventional study of Optive Plus® in the treatment of patients with dry eye: the prolipid study
Thomas Kaercher,1 Ulrich Thelen,2 Gerrett Brief,3 Robert J Morgan-Warren,4 Richard Leaback41Augenarztpraxis, Heidelberg, Germany; 2University of Münster, Münster, Germany; 3Ruhr University, Bochum, Germany; 4Allergan Holdings Ltd, Marlow, UK Objective: The aim was to ev...
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Dove Medical Press
2014
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oai:doaj.org-article:c82b211bd92d420689b757fe9f5514532021-12-02T12:26:24ZA prospective, multicenter, noninterventional study of Optive Plus® in the treatment of patients with dry eye: the prolipid study1177-5483https://doaj.org/article/c82b211bd92d420689b757fe9f5514532014-06-01T00:00:00Zhttp://www.dovepress.com/a-prospective-multicenter-noninterventional-study-of-optive-plusreg-in-a17220https://doaj.org/toc/1177-5483 Thomas Kaercher,1 Ulrich Thelen,2 Gerrett Brief,3 Robert J Morgan-Warren,4 Richard Leaback41Augenarztpraxis, Heidelberg, Germany; 2University of Münster, Münster, Germany; 3Ruhr University, Bochum, Germany; 4Allergan Holdings Ltd, Marlow, UK Objective: The aim was to evaluate the efficacy of Optive Plus®, an artificial tear containing castor oil, in patients with dry eye, in a routine clinical setting. Methods: This was a prospective, noninterventional study of patients with dry eye who switched from a prior therapy or who were naïve to treatment (n=1,209). Patients were issued Optive Plus® artificial tears. Dry eye severity, tear break-up time (TBUT), Schirmer score, Ocular Surface Disease Index (OSDI) score, and patient assessment of symptoms were recorded at baseline and at the follow-up visit (4 weeks after starting Optive Plus®). Results: The cause of dry eye was determined to be aqueous deficiency, lipid deficiency, or a mixture of aqueous and lipid deficiency (in 19.5%, 20.1%, and 47.8%, respectively, of the total study population). The severity of dry eye decreased from baseline to the follow-up visit, showing a decrease of the more severe levels (2–4) and a concurrent increase in mild level (1) of the rating scale. Patients reported an improvement in dry eye symptoms over the duration of the study, specifically 74.2% (n=152), 85.4% (n=182), and 82.4% (n=417) of patients in the aqueous-deficient, lipid-deficient, and mixed-deficiency groups, respectively. TBUT was measured in 475 patients. Baseline measurements for mean and standard deviation were 9.0±3.5, 7.1±3.6, and 6.6±3.0 seconds for the aqueous-deficient, lipid-deficient, and mixed-deficiency groups, respectively. These increased to 10.5±3.5, 10.0±3.6, and 9.2±3.1 seconds at the final visit. Overall, 92.5% of all patients were satisfied with the use of Optive Plus®, and 86% said they would purchase Optive Plus®. Ten percent of patients reported adverse events, and 1.8% of all patients experienced treatment-related adverse events. Conclusion: Optive Plus® was well tolerated and effective in reducing the signs and symptoms of all types of dry eye but is recommended for lipid-deficient dry eye patients. Keywords: dry eye, lipid-deficient, aqueous-deficient, meibomian, hyperosmolarity, evaporativeKaercher TThelen UBrief GMorgan-Warren RJLeaback RDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2014, Iss default, Pp 1147-1155 (2014) |
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Ophthalmology RE1-994 |
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Ophthalmology RE1-994 Kaercher T Thelen U Brief G Morgan-Warren RJ Leaback R A prospective, multicenter, noninterventional study of Optive Plus® in the treatment of patients with dry eye: the prolipid study |
| description |
Thomas Kaercher,1 Ulrich Thelen,2 Gerrett Brief,3 Robert J Morgan-Warren,4 Richard Leaback41Augenarztpraxis, Heidelberg, Germany; 2University of Münster, Münster, Germany; 3Ruhr University, Bochum, Germany; 4Allergan Holdings Ltd, Marlow, UK Objective: The aim was to evaluate the efficacy of Optive Plus®, an artificial tear containing castor oil, in patients with dry eye, in a routine clinical setting. Methods: This was a prospective, noninterventional study of patients with dry eye who switched from a prior therapy or who were naïve to treatment (n=1,209). Patients were issued Optive Plus® artificial tears. Dry eye severity, tear break-up time (TBUT), Schirmer score, Ocular Surface Disease Index (OSDI) score, and patient assessment of symptoms were recorded at baseline and at the follow-up visit (4 weeks after starting Optive Plus®). Results: The cause of dry eye was determined to be aqueous deficiency, lipid deficiency, or a mixture of aqueous and lipid deficiency (in 19.5%, 20.1%, and 47.8%, respectively, of the total study population). The severity of dry eye decreased from baseline to the follow-up visit, showing a decrease of the more severe levels (2–4) and a concurrent increase in mild level (1) of the rating scale. Patients reported an improvement in dry eye symptoms over the duration of the study, specifically 74.2% (n=152), 85.4% (n=182), and 82.4% (n=417) of patients in the aqueous-deficient, lipid-deficient, and mixed-deficiency groups, respectively. TBUT was measured in 475 patients. Baseline measurements for mean and standard deviation were 9.0±3.5, 7.1±3.6, and 6.6±3.0 seconds for the aqueous-deficient, lipid-deficient, and mixed-deficiency groups, respectively. These increased to 10.5±3.5, 10.0±3.6, and 9.2±3.1 seconds at the final visit. Overall, 92.5% of all patients were satisfied with the use of Optive Plus®, and 86% said they would purchase Optive Plus®. Ten percent of patients reported adverse events, and 1.8% of all patients experienced treatment-related adverse events. Conclusion: Optive Plus® was well tolerated and effective in reducing the signs and symptoms of all types of dry eye but is recommended for lipid-deficient dry eye patients. Keywords: dry eye, lipid-deficient, aqueous-deficient, meibomian, hyperosmolarity, evaporative |
| format |
article |
| author |
Kaercher T Thelen U Brief G Morgan-Warren RJ Leaback R |
| author_facet |
Kaercher T Thelen U Brief G Morgan-Warren RJ Leaback R |
| author_sort |
Kaercher T |
| title |
A prospective, multicenter, noninterventional study of Optive Plus® in the treatment of patients with dry eye: the prolipid study |
| title_short |
A prospective, multicenter, noninterventional study of Optive Plus® in the treatment of patients with dry eye: the prolipid study |
| title_full |
A prospective, multicenter, noninterventional study of Optive Plus® in the treatment of patients with dry eye: the prolipid study |
| title_fullStr |
A prospective, multicenter, noninterventional study of Optive Plus® in the treatment of patients with dry eye: the prolipid study |
| title_full_unstemmed |
A prospective, multicenter, noninterventional study of Optive Plus® in the treatment of patients with dry eye: the prolipid study |
| title_sort |
prospective, multicenter, noninterventional study of optive plus® in the treatment of patients with dry eye: the prolipid study |
| publisher |
Dove Medical Press |
| publishDate |
2014 |
| url |
https://doaj.org/article/c82b211bd92d420689b757fe9f551453 |
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