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
  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:


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.


Enrollment: 917
Study Start Date: October 2011
Study Completion Date: June 2013
Primary Completion Date: March 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Arizona Eye Center
Chandler, Arizona, United States
Arizona Center for Clinical Trials LLC
Phoenix, Arizona, United States
Cornea Consultants of Arizona
Phoenix, Arizona, United States
United States, California
Lugene Eye Institute
Glendale, California, United States
United Medical Research Institute
Inglewood, California, United States, 90301
Macy Eye Center
Los Angeles, California, United States, 90048
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States
Eye Research Foundation
Newport Beach, California, United States
North Bay Associates, Inc.
Petaluma, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States, 95670
Shasta Eye Medical Group, Inc.
Redding, California, United States
West Coast Eye Care Associates
San Diego, California, United States
San Diego Eye and Laser Center
San Diego, California, United States, 92123
United States, Florida
ZASA Clinical Research, LLC
Boynton Beach, Florida, United States
Florida Eye Microsurgicial Institute, Inc.
Boynton Beach, Florida, United States
Magruder Eye Institute
Orlando, Florida, United States
Vision Eye Care Center
Palm Springs, Florida, United States
International Research Center
Tampa, Florida, United States
United States, Kentucky
Richard Eiferman, MD
Louisville, Kentucky, United States
United States, Louisiana
Lakeview Optical
Gretna, Louisiana, United States
United States, Massachusetts
Center for Sight, Inc.
Fall River, Massachusetts, United States, 02720
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States
Ophthalmology Associates
St. Louis, Missouri, United States
Comprehensive Eye Care Ltd
Washington, Missouri, United States
United States, Nevada
Abrams Eye Institute
Las Vegas, Nevada, United States
Nevada Eye Care Professionals
Las Vegas, Nevada, United States
Eye Care Associates of Nevada
Sparks, Nevada, United States
United States, New Jersey
David Ringel, OD PA
Sewell, New Jersey, United States
United States, New York
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States
Ophthalmic Consultants of Long Island
Valley Stream, New York, United States
South Shore Eye Care
Wantagh, New York, United States
United States, North Carolina
Mundorf Eye Center
Charlotte, North Carolina, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
Charlotte, North Carolina, United States
James Branch, MD
Winston-Salem, North Carolina, United States
United States, Ohio
Eye Care Associates of Greater Cincinnati, Inc.
Cincinnati, Ohio, United States
Eye Care Associates of Greater Cincinnati, Inc.
Fairfield, Ohio, United States
Eye Care Associates of Greater Cincinnati, Inc.
Madeira, Ohio, United States
United States, Oregon
Roseburg Research Associates, LLC
Roseburg, Oregon, United States, 97471
United States, Pennsylvania
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States
Research Across America @ Wyomissing Optometric Center Inc
Wyomissing, Pennsylvania, United States
United States, Tennessee
Total Eye Care, PA
Memphis, Tennessee, United States
United States, Texas
David Shulman, MD
San Antonio, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
United States, Utah
Daynes Eye and Lasik
Salt Lake City, Utah, United States, 84103
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: June 11, 2013
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 August 28, 2014