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  • ||||||||||  Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    [VIRTUAL] Efficacy and Safety of KPI-121 0.25% for Short Term Relief in Dry Eye (STRIDE) (VM) -  May 23, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_2111;    
    P2, P3
    Conclusion In the completed Phase II and STRIDE 1 trials KPI-121 0.25% improved both signs and symptoms of DED when dosed QID for 2 weeks. KPI 121 appeared to be safe and well-tolerated and the incidence of IOP elevation, a known side effect with topical corticosteroids, was similar between the KPI-121 and vehicle arms in the completed trials.
  • ||||||||||  Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Trial completion, Trial completion date, Trial primary completion date:  STRIDE 3: Safety and Efficacy of KPI-121 in Subjects With DED (clinicaltrials.gov) -  May 6, 2020   
    P3,  N=901, Completed, 
    KPI 121 appeared to be safe and well-tolerated and the incidence of IOP elevation, a known side effect with topical corticosteroids, was similar between the KPI-121 and vehicle arms in the completed trials. Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Feb 2020 | Trial primary completion date: Jun 2020 --> Feb 2020
  • ||||||||||  Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Enrollment closed, Trial completion date, Trial primary completion date:  STRIDE 3: Safety and Efficacy of KPI-121 in Subjects With DED (clinicaltrials.gov) -  Mar 3, 2020   
    P3,  N=900, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Feb 2020 | Trial primary completion date: Jun 2020 --> Feb 2020 Recruiting --> Active, not recruiting | Trial completion date: Sep 2019 --> Jun 2020 | Trial primary completion date: Sep 2019 --> Jun 2020
  • ||||||||||  Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Efficacy and Safety of KPI-121 0.25% for Short Term Relief in Dry Eye (STRIDE) (BCEC-Meeting Level 1,Room 152) -  Mar 1, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_1091;    
    P2, P3
    Conclusion In the completed Phase II and STRIDE 1 trials KPI-121 0.25% improved both signs and symptoms of DED when dosed QID for 2 weeks. KPI 121 appeared to be safe and well-tolerated and the incidence of IOP elevation, a known side effect with topical corticosteroids, was similar between the KPI-121 and vehicle arms in the completed trials.
  • ||||||||||  Inveltys (loteprednol etabonate nano-suspension 1%) / Kala Pharma
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Surgery:  KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children (clinicaltrials.gov) -  Jan 10, 2019   
    P3,  N=2, Terminated, 
    The incidence of IOP elevation, a known side effect associated with topical corticosteroids use, was similar between the KPI-121 and vehicle arms in all three trials. N=60 --> 2 | Trial completion date: Feb 2020 --> Oct 2018 | Recruiting --> Terminated | Trial primary completion date: Feb 2020 --> Sep 2018; NDA #210565 did not trigger the need for a Pediatric Research Equity Act study.
  • ||||||||||  Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Trial completion:  STRIDE 2: Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease (clinicaltrials.gov) -  Jan 23, 2018   
    P3,  N=909, Completed, 
    N=60 --> 2 | Trial completion date: Feb 2020 --> Oct 2018 | Recruiting --> Terminated | Trial primary completion date: Feb 2020 --> Sep 2018; NDA #210565 did not trigger the need for a Pediatric Research Equity Act study. Recruiting --> Completed
  • ||||||||||  Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Trial primary completion date:  STRIDE 1: Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (clinicaltrials.gov) -  Mar 3, 2017   
    P3,  N=900, Recruiting, 
    Active, not recruiting --> Completed Trial primary completion date: Nov 2016 --> Jun 2017
  • ||||||||||  Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Enrollment closed, Enrollment change, Trial primary completion date:  Maui: Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease (clinicaltrials.gov) -  Feb 29, 2016   
    P2,  N=206, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=150 --> 206 | Trial primary completion date: Jul 2015 --> Feb 2016
  • ||||||||||  Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Trial primary completion date:  Maui: Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease (clinicaltrials.gov) -  Apr 14, 2015   
    P2,  N=150, Recruiting, 
    Recruiting --> Active, not recruiting | N=150 --> 206 | Trial primary completion date: Jul 2015 --> Feb 2016 Trial primary completion date: Feb 2015 --> Jul 2015
  • ||||||||||  Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Trial completion:  Kauai: Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (clinicaltrials.gov) -  Mar 31, 2015   
    P2,  N=150, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  Inveltys (loteprednol etabonate nano-suspension 1%) / Kala Pharma, Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Trial completion:  Hawaii-1: Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation (clinicaltrials.gov) -  Mar 31, 2015   
    P3,  N=380, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Enrollment closed, Trial primary completion date:  Kauai: Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (clinicaltrials.gov) -  Nov 25, 2014   
    P2,  N=150, Active, not recruiting, 
    Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2014 --> Jan 2015
  • ||||||||||  Inveltys (loteprednol etabonate nano-suspension 1%) / Kala Pharma, Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
    Enrollment closed:  Hawaii-1: Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation (clinicaltrials.gov) -  Nov 25, 2014   
    P3,  N=402, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2014 --> Jan 2015 Recruiting --> Active, not recruiting