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Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema (Molokini)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02245516
Recruitment Status : Completed
First Posted : September 19, 2014
Results First Posted : December 10, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE September 4, 2014
First Posted Date  ICMJE September 19, 2014
Results First Submitted Date  ICMJE August 18, 2020
Results First Posted Date  ICMJE December 10, 2020
Last Update Posted Date December 10, 2020
Study Start Date  ICMJE July 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2020)
  • Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: Day 1 to Day 57 ]
    Best Corrected Visual Acuity (BCVA) was measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. More letters read correctly results in a higher letter score, which represents better visual acuity.
  • Macular Volume by SD-OCT [ Time Frame: Day 1 to Day 57 ]
    Change in measurement (in microns) in macular volume as measured by Spectral Domain Optical Coherence Tomography (OCT)
  • Center Subfield Retinal Thickness by SD-OCT [ Time Frame: Day 1 to Day 57 ]
    Change in measurement (in microns) in the central subfield retinal thickness as measured by Spectral Domain Optical Coherence Tomography (OCT)
  • Investigator's Assessment of Leakage on the Fluorescein Angiogram [ Time Frame: Day 1 to Day 57 ]
    Change in leakage by investigator's assessment of the fluorescein angiogram
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2014)
  • Primary Efficacy [ Time Frame: Day 1 to Day 29 ]
    Summary statistics will include changes in BCVA by ETDRS
  • Primary Efficacy [ Time Frame: Day 1 to Day 29 ]
    Summary statistics will include changes in center subfield retinal thickness and macular volume by spectral domain optical coherence tomography (SD-OCT
  • Primary Efficacy [ Time Frame: Day 1 to Day 29 ]
    This exploratory study is not powered to test statistical hypotheses. Summary statistics will include changes in fluorescein angiography
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema
Official Title  ICMJE An Exploratory, Multi-Center, Randomized, Single-Masked Study Evaluating the Effect of KPI-121 on Intraretinal or Subretinal Fluid Secondary to Retinal Vein Occlusion or Diabetic Macular Edema
Brief Summary The primary objectives of the study are to evaluate the safety and effect of KPI-121 0.25% ophthalmic suspension and KPI-121 1.0% ophthalmic suspension on intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.
Detailed Description This is a multicenter, randomized, single-masked study evaluating the safety and effect of topical ocular administration of either KPI-121 0.25% ophthalmic suspension or KPI-121 1.0% ophthalmic suspension in subjects with intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Retinal Vein Occlusion
  • Diabetic Macular Edema
Intervention  ICMJE
  • Drug: KPI-121 0.25% Ophthalmic Suspension
    KPI-121 drug product will be supplied a 0.25% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
    Other Name: Loteprednol etabonate 0.25%
  • Drug: KPI-121 1.0% Ophthalmic Suspension
    KPI-121 drug product will be supplied a 1.0% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
    Other Name: Loteprednol etabonate 1.0%
Study Arms  ICMJE
  • Active Comparator: KPI-121 0.25% Ophthalmic Suspension
    KPI-121 0.25% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema
    Intervention: Drug: KPI-121 0.25% Ophthalmic Suspension
  • Active Comparator: KPI-121 1.0% Ophthalmic Suspension
    KPI-121 1.0% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema
    Intervention: Drug: KPI-121 1.0% Ophthalmic Suspension
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2015)
16
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2014)
15
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have documented presence of intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema at Screening

Exclusion Criteria:

  • Treatment with topical, intravitreal injection, posterior sub-Tenon's, or periocular corticosteroids within 120 days prior to Visit 1 and for the duration of the study
  • History of uncontrolled glaucoma, IOP over 21 mmHg at Visit 1, or are being treated for glaucoma in the study eye
  • Any significant ocular disease that could compromise vision in the study eye (including ongoing ocular infection, wet age-related macular degeneration, myopic degeneration with active subfoveal choroidal neovascularization)
  • Known hypersensitivity or contraindication to the investigational product(s) or their components
  • Diagnosis of severe/serious ocular condition that in the judgment of the Investigator could confound study assessments or limit compliance; or severe/serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments or limit compliance
  • Exposed to an investigational drug within 30 days prior to Visit 1 and for the duration of the study
  • In the opinion of the Investigator or study coordinator, an unwillingness or inability to comply with the study protocol or inability to successfully instill eye drops
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02245516
Other Study ID Numbers  ICMJE KPI-121-C-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kala Pharmaceuticals, Inc.
Study Sponsor  ICMJE Kala Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kala Pharmaceuticals, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP