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
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01102244
First received: April 9, 2010
Last updated: June 7, 2012
Last verified: January 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Blepharitis |
Drug: Tobradex ST Drug: Azasite |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Global sign and symptom score for blepharitis [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]
| Enrollment: | 122 |
| Study Start Date: | April 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
More Information
No publications provided by Alcon Research
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01102244 History of Changes |
| Other Study ID Numbers: | SMA-09-35 |
| Study First Received: | April 9, 2010 |
| Last Updated: | June 7, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
blepharitis moderate to severe chronic blepharitis |
Additional relevant MeSH terms:
|
Blepharitis Eyelid Diseases Eye Diseases Azithromycin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013