The Effects of Azithromycin Ophthalmic Solution, 1% Versus(vs) Placebo on Subjects With Blepharitis During a Two-Week Treatment Period

This study is currently recruiting participants.

Verified by Inspire Pharmaceuticals, May 2009

First Received: May 1, 2009 Last Updated: May 4, 2009 History of Changes

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00892970

Purpose

The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a two-week treatment period.

Condition	Intervention	Phase
Blepharitis	Drug: Azithromycin ophthalmic solution, 1% Drug: Placebo	Phase II

Drug Information available for: Azithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Eyelid margin erythema [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Signs and symptoms of Blepharitis [ Time Frame: One week, two weeks, three weeks, four weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	April 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Azithromycin ophthalmic solution, 1% One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days
2: Placebo Comparator	Drug: Placebo One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days

Eligibility

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

Criteria

Inclusion Criteria:

Have best corrected visual acuity in both eyes of at least +0.7 or better
If female, are non-pregnant or non-lactating
Have a current diagnosis of blepharitis in one or both eyes

Exclusion Criteria:

Have lid structural abnormalities
Have suspected ocular fungal or viral infection
Have practiced warm compress therapy within 14 days prior to Visit 2
Unable to withhold the use of contact lenses during the treatment or follow-up periods
Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits
Have had penetrating intraocular surgery within 90 days prior to Visit 2
Have had ocular surface surgery within the past year prior to Visit 2
Have a serious medical condition which could confound study assessments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892970

Contacts

Contact: Mike Schiewe

919-941-9777

mschiewe@inspirepharm.com

Locations

United States, California
Sall Medical Research Center	Recruiting
Artesia, California, United States
Principal Investigator: Kenneth Sall, MD

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Chair:

Reza Haque, MD, PhD

Medical Monitor, Inspire

More Information

No publications provided

Responsible Party:	Inspire ( Mike Schiewe )
Study ID Numbers:	044-101
Study First Received:	May 1, 2009
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00892970 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Bacterial Agents
Azithromycin
Eye Diseases
Blepharitis

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Azithromycin

Eye Diseases
Eyelid Diseases
Blepharitis
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009