Lifitegrast Ophthalmic Solution 5% Is a Safe and Efficient Eyedrop for Dry Eye Disease: A Systematic Review and Meta-Analysis
Abstract
:1. Introduction
2. Methods
2.1. Literature Search
2.2. Study Selection
2.3. Data Extraction and Risk-of-Bias Assessment
2.4. Statistical Analysis
3. Results
3.1. Characteristic of Included Studies
Risk of Bias of Included Studies
3.2. Efficacy Outcomes
3.2.1. Objective Evaluation
3.2.2. Subjective Evaluation
3.3. Safety Outcomes
4. Discussion
Strengths and Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
References
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Author, Year (Study Name) | N | Comparison | Age Mean | Age SD | Female (%) | Country | Duration of Study | Study Design | Blindness | ITT | Outcome Measurement |
---|---|---|---|---|---|---|---|---|---|---|---|
Sheppard et al., 2014 [9] (OPUS-1) | 588 | vehicle | 60.7 | 12.0 | 69.2 | US | 12 weeks | RCT | double | N/M | CFS, EDS, LGS, ODS, OSDI, TEAE, VAS |
Tauber et al., 2015 [10] (OPUS-2) | 718 | vehicle | 58.8 | 14.1 | 76.6 | US | 12 weeks | RCT | double | Yes | CFS, EDS, LGS, ODS, TEAE, VAS |
Holland et al., 2016 [11] (OPUS-3) | 711 | vehicle | 58.7 | 14.5 | 75.5 | US | 12 weeks | RCT | double | Yes | EDS, ODS, TEAE, VAS |
Donnenfeld et al., 2016 [12] (SONATA) | 332 | vehicle | 59.5 | 12.7 | 75.3 | US | 360 days | RCT | double | N/M | post-instillation comfort, TEAE |
De Paz et al., 2017 [13] | 14 | - | 44.9 | 3.1 | 85.8 | US | 4 weeks | case-control | none | N/M | ODSI |
Tauber et al., 2019 [14] | 50 | TPP | 65.8 | 8.9 | 80.0 | US | 6 weeks | RCT | single | N/M | BCVA, bulbar conjunctival injection, CFS, lipid layer thickness, meibomian gland patency, MGD score, MMP-9, VAS |
Tong et al., 2019 [15] | 121 | - | 60.5 | 14.4 | 87.6 | US | 12 weeks | retrospective cohort | none | N/M | CFS, MGD score, OSDI, TBUT, TEAE |
Pepose et al., 2019 [16] | 30 | - | 67.4 | - | 88.5 | US | 12 weeks | longitudinal | none | Yes | CFS, MGD score, TBUT, tear osmolality, VAS |
Epitropoulos et al., 2020 [17] | 33 | CYC | 69.3 | 4.2 | 78.8 | US | 3 weeks | retrospective cohort | none | N/M | VAS |
Hovanesian et al., 2021 [18] | 600 | - | 57.1 | - | 75.8 | US/Canada | 12 months | retrospective cohort | none | N/M | CFS, DEQ-5, ODSI, Schirmer score, SPEED, TBUT |
Variables | Studies Included | Lifitegrast | Placebo | N | Risk Ratio | 95% Cl | p | |||
---|---|---|---|---|---|---|---|---|---|---|
Event | Total | Event | Total | Lower Limit | Upper Limit | |||||
Subjects with ≥1 TEAE | 3 | 504 | 936 | 238 | 824 | 1760 | 2.87 | 2.36 | 3.50 | <0.001 |
Subjects with ≥1 ocular TEAE | 4 | 552 | 1229 | 233 | 1119 | 2348 | 3.10 | 2.58 | 3.72 | <0.001 |
Instillation site irritation | 4 | 195 | 1229 | 33 | 1119 | 2348 | 6.21 | 4.25 | 9.06 | <0.001 |
Instillation site pain | 1 | 63 | 293 | 11 | 295 | 588 | 7.07 | 3.64 | 13.73 | <0.001 |
Instillation site reaction | 4 | 149 | 1229 | 37 | 1119 | 2348 | 4.03 | 2.79 | 5.84 | <0.001 |
Instillation site pruritus | 1 | 19 | 293 | 6 | 295 | 588 | 3.34 | 1.31 | 8.49 | 0.011 |
Visual acuity reduced | 3 | 55 | 872 | 43 | 765 | 1637 | 1.13 | 0.75 | 1.71 | 0.559 |
Eye pain | 1 | 6 | 293 | 5 | 295 | 588 | 1.21 | 0.37 | 4.02 | 0.753 |
Lacrimation increased | 1 | 7 | 293 | 1 | 295 | 588 | 7.20 | 0.88 | 58.86 | 0.066 |
Eye pruritus | 1 | 5 | 293 | 2 | 295 | 588 | 2.54 | 0.49 | 13.22 | 0.267 |
Ocular hyperemia | 1 | 7 | 293 | 4 | 295 | 588 | 1.78 | 0.52 | 6.15 | 0.362 |
Subjects with ≥1 non-ocular TEAE | 3 | 284 | 936 | 114 | 824 | 1760 | 2.71 | 2.13 | 3.46 | <0.001 |
Nervous system disorders | 1 | 63 | 359 | 11 | 359 | 588 | 6.73 | 3.48 | 13.01 | <0.001 |
Dysgeusia | 3 | 140 | 936 | 4 | 824 | 1760 | 36.06 | 13.28 | 97.88 | <0.001 |
Withdrawal due to ≥1 TEAE | 4 | 83 | 1229 | 25 | 1119 | 2348 | 3.17 | 2.01 | 4.99 | <0.001 |
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Li, J.-X.; Tsai, Y.-Y.; Lai, C.-T.; Li, Y.-L.; Wu, Y.-H.; Chiang, C.-C. Lifitegrast Ophthalmic Solution 5% Is a Safe and Efficient Eyedrop for Dry Eye Disease: A Systematic Review and Meta-Analysis. J. Clin. Med. 2022, 11, 5014. https://doi.org/10.3390/jcm11175014
Li J-X, Tsai Y-Y, Lai C-T, Li Y-L, Wu Y-H, Chiang C-C. Lifitegrast Ophthalmic Solution 5% Is a Safe and Efficient Eyedrop for Dry Eye Disease: A Systematic Review and Meta-Analysis. Journal of Clinical Medicine. 2022; 11(17):5014. https://doi.org/10.3390/jcm11175014
Chicago/Turabian StyleLi, Jing-Xing, Yi-Yu Tsai, Chun-Ting Lai, You-Ling Li, Ying-Hsuen Wu, and Chun-Chi Chiang. 2022. "Lifitegrast Ophthalmic Solution 5% Is a Safe and Efficient Eyedrop for Dry Eye Disease: A Systematic Review and Meta-Analysis" Journal of Clinical Medicine 11, no. 17: 5014. https://doi.org/10.3390/jcm11175014