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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. Identifier: NCT01408082
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : October 25, 2019
Information provided by (Responsible Party):
Sun Pharma Global FZE

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.

Condition or disease Intervention/treatment Phase
Blepharitis Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined) Drug: Azasite Drug: Dexamethasone Other: Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 917 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: ISV-502 Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Azithromycin and Dexamethasone twice daily for 2 weeks
Other Name: AzaSite Plus

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

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01408082

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Sponsors and Collaborators
Sun Pharma Global FZE
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sun Pharma Global FZE Identifier: NCT01408082    
Other Study ID Numbers: C-10-502-004
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: April 2015
Additional relevant MeSH terms:
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Eyelid Diseases
Eye Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
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