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

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01102244
Collaborator
(none)
122
1
2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tobradex ST

tobramycin 0.3%, dexamethasone 0.05%

Drug: Tobradex ST
tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days

Active Comparator: Azasite

azithromycin 1%

Drug: Azasite
azithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days

Outcome Measures

Primary Outcome Measures

  1. Global sign and symptom score for blepharitis [Day 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ora Andover Massachusetts United States 01810

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01102244
Other Study ID Numbers:
  • SMA-09-35
First Posted:
Apr 13, 2010
Last Update Posted:
Jun 11, 2012
Last Verified:
Jan 1, 2011
Keywords provided by Alcon Research
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 11, 2012