Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial
Peter A Simmons, Cindy Carlisle-Wilcox, Joseph G Vehige Ophthalmology Research and Development, Allergan, Inc., Irvine, CA, USA Background: Dry eye may be caused or exacerbated by deficient lipid secretion. Recently, lipid-containing artificial tears have been developed to alleviate this deficienc...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2015-04-01
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| Series: | Clinical Ophthalmology |
| Online Access: | http://www.dovepress.com/comparison-of-novel-lipid-based-eye-drops-with-aqueous-eye-drops-for-d-peer-reviewed-article-OPTH |
| _version_ | 1819015925206089728 |
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| author | Simmons PA Carlisle-Wilcox C Vehige JG |
| author_facet | Simmons PA Carlisle-Wilcox C Vehige JG |
| author_sort | Simmons PA |
| collection | DOAJ |
| description | Peter A Simmons, Cindy Carlisle-Wilcox, Joseph G Vehige Ophthalmology Research and Development, Allergan, Inc., Irvine, CA, USA Background: Dry eye may be caused or exacerbated by deficient lipid secretion. Recently, lipid-containing artificial tears have been developed to alleviate this deficiency. Our study compared the efficacy, safety, and acceptability of lipid-containing eye drops with that of aqueous eye drops.Methods: A non-inferiority, randomized, parallel-group, investigator-masked multicenter trial was conducted. Subjects with signs and symptoms of dry eye were randomized to use one of two lipid-containing artificial tears, or one of two aqueous artificial tears. Subjects instilled assigned drops in each eye at least twice daily for 30 days. The primary efficacy analysis tested non-inferiority of a preservative-free lipid tear formulation (LT UD) to a preservative-free aqueous tear formulation (AqT UD) for change in Ocular Surface Disease Index (OSDI) score from baseline at day 30. Secondary measures included OSDI at day 7, tear break-up time (TBUT), corneal and conjunctival staining, Schirmer’s test, acceptability and usage questionnaires, and safety assessments.Results: A total of 315 subjects were randomized and included in the analyses. Subjects reported instilling a median of three doses of study eye drops per day in all groups. At days 7 and 30, all groups showed statistically significant improvements from baseline in OSDI (P<0.001) and TBUT (P≤0.005). LT UD was non-inferior to AqT UD for mean change from baseline in OSDI score at day 30. No consistent or clinically relevant differences for the other efficacy variables were observed. Acceptability was generally similar across the groups and there was a low incidence of adverse events.Conclusion: In this heterogeneous population of dry eye subjects, there were no clinically significant differences in safety, effectiveness, and acceptability between lipid-containing artificial tears and aqueous eye drops. The results suggest that lipid-containing artificial tears can be used to counteract lipid deficiency that is common in dry eye, without compromising overall acceptability. Keywords: artificial tears, emulsion, dry eye, Ocular Surface Disease Index, tear break-up time, tear film lipid layer |
| first_indexed | 2024-12-21T02:39:28Z |
| format | Article |
| id | doaj.art-b020ec35e7644e8cb38a1877172d0bf6 |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-12-21T02:39:28Z |
| publishDate | 2015-04-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-b020ec35e7644e8cb38a1877172d0bf62022-12-21T19:18:42ZengDove Medical PressClinical Ophthalmology1177-54832015-04-012015default65766421337Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trialSimmons PACarlisle-Wilcox CVehige JGPeter A Simmons, Cindy Carlisle-Wilcox, Joseph G Vehige Ophthalmology Research and Development, Allergan, Inc., Irvine, CA, USA Background: Dry eye may be caused or exacerbated by deficient lipid secretion. Recently, lipid-containing artificial tears have been developed to alleviate this deficiency. Our study compared the efficacy, safety, and acceptability of lipid-containing eye drops with that of aqueous eye drops.Methods: A non-inferiority, randomized, parallel-group, investigator-masked multicenter trial was conducted. Subjects with signs and symptoms of dry eye were randomized to use one of two lipid-containing artificial tears, or one of two aqueous artificial tears. Subjects instilled assigned drops in each eye at least twice daily for 30 days. The primary efficacy analysis tested non-inferiority of a preservative-free lipid tear formulation (LT UD) to a preservative-free aqueous tear formulation (AqT UD) for change in Ocular Surface Disease Index (OSDI) score from baseline at day 30. Secondary measures included OSDI at day 7, tear break-up time (TBUT), corneal and conjunctival staining, Schirmer’s test, acceptability and usage questionnaires, and safety assessments.Results: A total of 315 subjects were randomized and included in the analyses. Subjects reported instilling a median of three doses of study eye drops per day in all groups. At days 7 and 30, all groups showed statistically significant improvements from baseline in OSDI (P<0.001) and TBUT (P≤0.005). LT UD was non-inferior to AqT UD for mean change from baseline in OSDI score at day 30. No consistent or clinically relevant differences for the other efficacy variables were observed. Acceptability was generally similar across the groups and there was a low incidence of adverse events.Conclusion: In this heterogeneous population of dry eye subjects, there were no clinically significant differences in safety, effectiveness, and acceptability between lipid-containing artificial tears and aqueous eye drops. The results suggest that lipid-containing artificial tears can be used to counteract lipid deficiency that is common in dry eye, without compromising overall acceptability. Keywords: artificial tears, emulsion, dry eye, Ocular Surface Disease Index, tear break-up time, tear film lipid layerhttp://www.dovepress.com/comparison-of-novel-lipid-based-eye-drops-with-aqueous-eye-drops-for-d-peer-reviewed-article-OPTH |
| spellingShingle | Simmons PA Carlisle-Wilcox C Vehige JG Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial Clinical Ophthalmology |
| title | Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial |
| title_full | Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial |
| title_fullStr | Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial |
| title_full_unstemmed | Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial |
| title_short | Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial |
| title_sort | comparison of novel lipid based eye drops with aqueous eye drops for dry eye a multicenter randomized controlled trial |
| url | http://www.dovepress.com/comparison-of-novel-lipid-based-eye-drops-with-aqueous-eye-drops-for-d-peer-reviewed-article-OPTH |
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