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

Sponsor

Sun Pharmaceutical Industries Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT01408082

Collaborator

(none)

917

Enrollment

Locations

Arms

Duration (Months)

20.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Oct 1, 2011

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

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 Names: 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

Outcome Measures

Primary Outcome Measures

Clinical Resolution [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.
Recurrence of Clinical Signs and Symptoms [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Arizona Eye Center	Chandler	Arizona	United States
2	Arizona Center for Clinical Trials LLC	Phoenix	Arizona	United States
3	Cornea Consultants of Arizona	Phoenix	Arizona	United States
4	Lugene Eye Institute	Glendale	California	United States
5	United Medical Research Institute	Inglewood	California	United States	90301
6	Macy Eye Center	Los Angeles	California	United States	90048
7	North Valley Eye Medical Group, Inc.	Mission Hills	California	United States
8	Eye Research Foundation	Newport Beach	California	United States
9	North Bay Associates, Inc.	Petaluma	California	United States
10	Martel Eye Medical Group	Rancho Cordova	California	United States	95670
11	Shasta Eye Medical Group, Inc.	Redding	California	United States
12	San Diego Eye and Laser Center	San Diego	California	United States	92123
13	West Coast Eye Care Associates	San Diego	California	United States
14	Florida Eye Microsurgicial Institute, Inc.	Boynton Beach	Florida	United States
15	ZASA Clinical Research, LLC	Boynton Beach	Florida	United States
16	Magruder Eye Institute	Orlando	Florida	United States
17	Vision Eye Care Center	Palm Springs	Florida	United States
18	International Research Center	Tampa	Florida	United States
19	Richard Eiferman, MD	Louisville	Kentucky	United States
20	Lakeview Optical	Gretna	Louisiana	United States
21	Center for Sight, Inc.	Fall River	Massachusetts	United States	02720
22	Tauber Eye Center	Kansas City	Missouri	United States
23	Ophthalmology Associates	Saint Louis	Missouri	United States
24	Comprehensive Eye Care Ltd	Washington	Missouri	United States
25	Abrams Eye Institute	Las Vegas	Nevada	United States
26	Nevada Eye Care Professionals	Las Vegas	Nevada	United States
27	Eye Care Associates of Nevada	Sparks	Nevada	United States
28	David Ringel, OD PA	Sewell	New Jersey	United States
29	Ophthalmic Consultants of Long Island	Lynbrook	New York	United States
30	Ophthalmic Consultants of Long Island	Rockville Centre	New York	United States
31	Ophthalmic Consultants of Long Island	Valley Stream	New York	United States
32	South Shore Eye Care	Wantagh	New York	United States
33	Charlotte Eye Ear Nose & Throat Associates, P.A.	Charlotte	North Carolina	United States
34	Mundorf Eye Center	Charlotte	North Carolina	United States
35	James Branch, MD	Winston-Salem	North Carolina	United States
36	Eye Care Associates of Greater Cincinnati, Inc.	Cincinnati	Ohio	United States
37	Eye Care Associates of Greater Cincinnati, Inc.	Fairfield	Ohio	United States
38	Eye Care Associates of Greater Cincinnati, Inc.	Madeira	Ohio	United States
39	Roseburg Research Associates, LLC	Roseburg	Oregon	United States	97471
40	Philadelphia Eye Associates	Philadelphia	Pennsylvania	United States
41	Research Across America @ Wyomissing Optometric Center Inc	Wyomissing	Pennsylvania	United States
42	Total Eye Care, PA	Memphis	Tennessee	United States
43	David Shulman, MD	San Antonio	Texas	United States
44	Sun Research Institute	San Antonio	Texas	United States
45	Daynes Eye and Lasik	Salt Lake City	Utah	United States	84103