drugset / Trial / NCT03451396
Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms
Non-randomizedParallel-groupOpen-labelTreatment
Summary
To determine whether a fall in tear osmolarity precedes improvement in symptoms and signs of dry eye in dry eye patients treated topically with 5% lifitegrast drops for 3 months.
Timeline
- Start
- 2016-12-12
- Primary completion
- 2018-02-01
- Completion
- 2018-03-15
Publications
- Results Holland EJ, Whitley WO, Sall K, Lane SS, Raychaudhuri A, Zhang SY, Shojaei A. Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials. Curr Med Res Opin. 2016 Oct;32(10):1759-1765. doi: 10.1080/03007995.2016.1210107. Epub 2016 Jul 22.
- Results Donnenfeld ED, Karpecki PM, Majmudar PA, Nichols KK, Raychaudhuri A, Roy M, Semba CP. Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study. Cornea. 2016 Jun;35(6):741-8. doi: 10.1097/ICO.0000000000000803.
- Results Sullivan BD, Crews LA, Sonmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lifitegrast | Unknown | 5 % | Topical |