Edward J Holland1, Walter O Whitley2, Kenneth Sall3, Stephen S Lane4, Aparna Raychaudhuri5, Steven Y Zhang6, Amir Shojaei6. 1. a Cincinnati Eye Institute , Cincinnati , OH , USA. 2. b Virginia Eye Consultants , Norfolk , VA , USA. 3. c Sall Research Medical Center , Artesia , CA , USA. 4. d Associated Eye Care , Stillwater , MN , USA. 5. e Shire , Wayne , PA , USA (at the time of this work). 6. f Shire , Lexington , MA , USA.
Abstract
OBJECTIVE: Report efficacy findings from three clinical trials (one phase 2 and two phase 3 [OPUS-1, OPUS-2]) of lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease (DED). RESEARCH DESIGN AND METHODS: Three 84-day, randomized, double-masked, placebo-controlled trials. Adults (≥18 years) with DED were randomized (1:1) to lifitegrast 5.0% or matching placebo. Changes from baseline to day 84 in signs and symptoms of DED were analyzed. MAIN OUTCOME MEASURES: Phase 2, pre-specified endpoint: inferior corneal staining score (ICSS; 0-4); OPUS-1, coprimary endpoints: ICSS and visual-related function subscale (0-4 scale); OPUS-2, coprimary endpoints: ICSS and eye dryness score (EDS, VAS; 0-100). RESULTS:Fifty-eight participants were randomized to lifitegrast 5.0% and 58 to placebo in the phase 2 trial; 293 to lifitegrast and 295 to placebo in OPUS-1; 358 to lifitegrast and 360 to placebo in OPUS-2. In participants with mild-to-moderate baseline DED symptomatology, lifitegrast improved ICSS versus placebo in the phase 2 study (treatment effect, 0.35; 95% CI, 0.05-0.65; p = 0.0209) and OPUS-1 (effect, 0.24; 95% CI, 0.10-0.38; p = 0.0007). Among more symptomatic participants (baseline EDS ≥40, recent artificial tear use), lifitegrast improved EDS versus placebo in a post hoc analysis of OPUS-1 (effect, 13.34; 95% CI, 2.35-24.33; nominal p = 0.0178) and in OPUS-2 (effect, 12.61; 95% CI, 8.51-16.70; p < 0.0001). LIMITATIONS: Trials were conducted over 12 weeks; efficacy beyond this period was not assessed. CONCLUSIONS: Across three trials, lifitegrast improved ICSS in participants with mild-to-moderate baseline symptomatology in two studies, and EDS in participants with moderate-to-severe baseline symptomatology in two studies. Based on the overall findings from these trials, lifitegrast shows promise as a new treatment option for signs and symptoms of DED.
RCT Entities:
OBJECTIVE: Report efficacy findings from three clinical trials (one phase 2 and two phase 3 [OPUS-1, OPUS-2]) of lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease (DED). RESEARCH DESIGN AND METHODS: Three 84-day, randomized, double-masked, placebo-controlled trials. Adults (≥18 years) with DED were randomized (1:1) to lifitegrast 5.0% or matching placebo. Changes from baseline to day 84 in signs and symptoms of DED were analyzed. MAIN OUTCOME MEASURES: Phase 2, pre-specified endpoint: inferior corneal staining score (ICSS; 0-4); OPUS-1, coprimary endpoints: ICSS and visual-related function subscale (0-4 scale); OPUS-2, coprimary endpoints: ICSS and eye dryness score (EDS, VAS; 0-100). RESULTS: Fifty-eight participants were randomized to lifitegrast 5.0% and 58 to placebo in the phase 2 trial; 293 to lifitegrast and 295 to placebo in OPUS-1; 358 to lifitegrast and 360 to placebo in OPUS-2. In participants with mild-to-moderate baseline DED symptomatology, lifitegrast improved ICSS versus placebo in the phase 2 study (treatment effect, 0.35; 95% CI, 0.05-0.65; p = 0.0209) and OPUS-1 (effect, 0.24; 95% CI, 0.10-0.38; p = 0.0007). Among more symptomatic participants (baseline EDS ≥40, recent artificial tear use), lifitegrast improved EDS versus placebo in a post hoc analysis of OPUS-1 (effect, 13.34; 95% CI, 2.35-24.33; nominal p = 0.0178) and in OPUS-2 (effect, 12.61; 95% CI, 8.51-16.70; p < 0.0001). LIMITATIONS: Trials were conducted over 12 weeks; efficacy beyond this period was not assessed. CONCLUSIONS: Across three trials, lifitegrast improved ICSS in participants with mild-to-moderate baseline symptomatology in two studies, and EDS in participants with moderate-to-severe baseline symptomatology in two studies. Based on the overall findings from these trials, lifitegrast shows promise as a new treatment option for signs and symptoms of DED.
Authors: Kelly K Nichols; Eric D Donnenfeld; Paul M Karpecki; John A Hovanesian; Aparna Raychaudhuri; Amir Shojaei; Steven Zhang Journal: Eur J Ophthalmol Date: 2018-08-16 Impact factor: 2.597
Authors: Raffaela Patrícia da Silva Soares; Ana Paula Nunes de Lima Fernandes; Fabiane Rocha Botarelli; Jéssica Naiara de Medeiros Araújo; Jéssica de Araújo Olímpio; Allyne Fortes Vitor Journal: Rev Lat Am Enfermagem Date: 2019-10-28