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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01408082
First received: August 1, 2011
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Blepharitis
 Drug: ISV-502
Drug: Azasite
Drug: Dexamethasone
Other: Vehicle
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by InSite Vision:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 900
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISV-502 Drug: ISV-502
Azithromycin and Dexamethasone twice daily for 2 weeks
Active Comparator: AzaSite Drug: Azasite
Azasite twice daily for 2 weeks
Active Comparator: Dexamethasone Drug: Dexamethasone
Dexamethasone twice daily for 2 weeks
Placebo Comparator: Vehicle Other: Vehicle
Vehicle twice daily for 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408082

  Show 45 Study Locations
Sponsors and Collaborators
InSite Vision
  More Information

No publications provided

Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT01408082     History of Changes
Other Study ID Numbers: C-10-502-004
Study First Received: August 1, 2011
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Azithromycin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 16, 2013