A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic Blepharitis

Blepharitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102244
• Other study ID #: SMA-09-35
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2010
• Last updated: June 7, 2012
• Start date: April 2010

Study information

• Verified date: January 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy and safety of Tobradex ST compared to AzaSite in the treatment of moderate to severe chronic blepharitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have diagnosis of moderate to severe chronic blepharitis defined by a minimum score of at least "1" for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye

• Have a minimum global score (the total signs and symptoms score) of 5 in the same eye qualifying.

Exclusion Criteria:

• Have known sensitivity or poor tolerance to the test article (tobramycin, dexamethasone, azithromycin) or its components or any therapy associated with the trial

• Have a history of ocular surgical intervention within six (6) weeks prior to Visit 1 or during the study

• Have any ocular infections (bacterial, viral or fungal) - active ocular inflammation (i.e. follicular conjunctivitis, iritis) or preauricular lymphadenopathy, other than blepharitis

• Have worn contact lenses in the 72 hours prior to visit 1 and for the duration of the study

• Are currently taking any medication known to cause ocular drying that has not been on a stable dose for at least 30 days

• Have used any topical ocular or systemic antibiotics within 7 days of enrollment. Stable (greater than 1 month prior to enrollment) use of topical antibiotics on the face (except around the eyes) for dermatologic conditions is allowed. Dose must continue unchanged for duration of study

• Have used any topical ocular - aerosolized/nebulized - or systemic corticosteroid agents within 14 days of enrollment. Stable (greater than 1 month prior to enrollment) use of inhaled (using mouthpiece) and nasal corticosteroids and topical dermal steroids (except around the eyelids) are allowed. Dose must continue unchanged for the duration of the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• Tobradex ST
tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days
• Azasite
azithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days

Locations

Country	Name	City	State
United States	Ora	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global sign and symptom score for blepharitis		Day 15	Yes