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Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis (DOUBle)

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: NCT01408082
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
InSite Vision

Tracking Information
First Submitted Date  ICMJE August 1, 2011
First Posted Date  ICMJE August 3, 2011
Last Update Posted Date May 6, 2015
Study Start Date  ICMJE October 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2011)
  • Clinical Resolution [ Time Frame: Day 15 ]
    The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
  • Recurrence of Clinical Signs and Symptoms [ Time Frame: 6 Month ]
    The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
  • Clinical Resolution [ Time Frame: Day 15 ]
    The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution (score of 0) of signs and symptoms at Day 15.
  • Recurrence of Clinical Signs and Symptoms [ Time Frame: 6 Month ]
    The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by Visit 10 (6-Month Follow-up). Recurrence is defined as a score of ≥4 from Day 15 in the study eye and must include a score of 1 for eyelid redness and a score of 1 for eyelid irritation.
Change History Complete list of historical versions of study NCT01408082 on ClinicalTrials.gov Archive Site
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 Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
Official Title  ICMJE A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-502 Compared to AzaSite Alone, Dexamethasone Alone, and Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis
Brief Summary The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Blepharitis
Intervention  ICMJE
  • Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
    Azithromycin and Dexamethasone twice daily for 2 weeks
    Other Name: AzaSite Plus
  • Drug: Azasite
    Azasite twice daily for 2 weeks
  • Drug: Dexamethasone
    Dexamethasone twice daily for 2 weeks
  • Other: Vehicle
    Vehicle twice daily for 2 weeks
Study Arms  ICMJE
  • Experimental: ISV-502
    Intervention: Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
  • Active Comparator: AzaSite
    Intervention: Drug: Azasite
  • Active Comparator: Dexamethasone
    Intervention: Drug: Dexamethasone
  • Placebo Comparator: Vehicle
    Intervention: Other: Vehicle
Publications * Hosseini K, Bourque LB, Hays RD. Development and evaluation of a measure of patient-reported symptoms of Blepharitis. Health Qual Life Outcomes. 2018 Jan 11;16(1):11. doi: 10.1186/s12955-018-0839-5.

*   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: June 11, 2013)
917
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2011)
900
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.
  • Signature of the subject or legally authorized representative on the Informed Consent Form.
  • Are willing and able to follow all instructions and attend all study visits.
  • Are willing to avoid disallowed medication for the duration of the study.
  • If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months.
  • Additional inclusion criteria also apply.

Exclusion Criteria:

  • Have known sensitivity or poor tolerance to any component of the Investigational Drug.
  • Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye.
  • Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters.
  • Have used any non-diagnostic topical ophthalmic solutions in the study eye.
  • Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test.
  • Currently suffer from alcohol and/or drug abuse.
  • Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an investigational drug or device.
  • Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
  • Additional exclusion criteria also apply.
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 NCT01408082
Other Study ID Numbers  ICMJE C-10-502-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InSite Vision
Study Sponsor  ICMJE InSite Vision
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InSite Vision
Verification Date April 2015

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