Clinical trial NCT01408082: Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blepharitis
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2011-08-03
Enrollment: 917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Clinical Resolution
timeFrame: Day 15
measure: Recurrence of Clinical Signs and Symptoms
timeFrame: 6 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Center for Clinical Trials LLC
state: Arizona
city: Phoenix
country: United States
facility: Cornea Consultants of Arizona
state: Arizona
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: Macy Eye Center
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc.
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Associates, Inc.
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Redding
country: United States
facility: Shasta Eye Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: San Diego Eye and Laser Center
state: California
city: San Diego
country: United States
facility: West Coast Eye Care Associates
state: California
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgicial Institute, Inc.
state: Florida
city: Boynton Beach
country: United States
facility: ZASA Clinical Research, LLC
state: Florida
city: Orlando
country: United States
facility: Magruder Eye Institute
state: Florida
city: Palm Springs
country: United States
facility: Vision Eye Care Center
state: Florida
city: Tampa
country: United States
facility: International Research Center
state: Florida
city: Louisville
country: United States
facility: Richard Eiferman, MD
state: Kentucky
city: Gretna
country: United States
facility: Lakeview Optical
state: Louisiana
city: Fall River
country: United States
facility: Center for Sight, Inc.
state: Massachusetts
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care Ltd
state: Missouri
city: Las Vegas
country: United States
facility: Abrams Eye Institute
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Eye Care Professionals
state: Nevada
city: Sparks
country: United States
facility: Eye Care Associates of Nevada
state: Nevada
city: Sewell
country: United States
facility: David Ringel, OD PA
state: New Jersey
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Valley Stream
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Care
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates, P.A.
state: North Carolina
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: Winston-Salem
country: United States
facility: James Branch, MD
state: North Carolina
city: Cincinnati
country: United States
facility: Eye Care Associates of Greater Cincinnati, Inc.
state: Ohio
city: Fairfield
country: United States
facility: Eye Care Associates of Greater Cincinnati, Inc.
state: Ohio
city: Madeira
country: United States
facility: Eye Care Associates of Greater Cincinnati, Inc.
state: Ohio
city: Roseburg
country: United States
facility: Roseburg Research Associates, LLC
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
city: Wyomissing
country: United States
facility: Research Across America @ Wyomissing Optometric Center Inc
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: San Antonio
country: United States
facility: David Shulman, MD
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: Daynes Eye and Lasik
state: Utah
Study officials:
References:
citation: 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.