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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01408082
First received: August 1, 2011
Last updated: June 11, 2013
Last verified: June 2013

August 1, 2011
June 11, 2013
October 2011
March 2013   (final data collection date for primary outcome measure)
  • Clinical Resolution [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
  • Clinical Resolution [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
Complete list of historical versions of study NCT01408082 on ClinicalTrials.gov Archive Site
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Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Blepharitis
  • Drug: ISV-502
    Azithromycin and Dexamethasone twice daily for 2 weeks
  • Drug: Azasite
    Azasite twice daily for 2 weeks
  • Drug: Dexamethasone
    Dexamethasone twice daily for 2 weeks
  • Other: Vehicle
    Vehicle twice daily for 2 weeks
  • Experimental: ISV-502
    Intervention: Drug: ISV-502
  • Active Comparator: AzaSite
    Intervention: Drug: Azasite
  • Active Comparator: Dexamethasone
    Intervention: Drug: Dexamethasone
  • Placebo Comparator: Vehicle
    Intervention: Other: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
917
June 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01408082
C-10-502-004
Not Provided
InSite Vision
InSite Vision
Not Provided
Not Provided
InSite Vision
June 2013

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