NCT01102244

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

June 11, 2012

Status Verified

January 1, 2011

Enrollment Period

2 months

First QC Date

April 9, 2010

Last Update Submit

June 7, 2012

Conditions

Blepharitis

Keywords

blepharitismoderate to severe chronic blepharitis

Outcome Measures

Primary Outcomes (1)

  • Global sign and symptom score for blepharitis

    Day 15

Study Arms (2)

Tobradex ST

EXPERIMENTAL

tobramycin 0.3%, dexamethasone 0.05%

Drug: Tobradex ST

Azasite

ACTIVE COMPARATOR

azithromycin 1%

Drug: Azasite

Interventions

Tobradex STDRUG

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

Tobradex ST
AzasiteDRUG

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

Azasite

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ora

Andover, Massachusetts, 01810, United States

Location

Related Publications (1)

  • Torkildsen GL, Cockrum P, Meier E, Hammonds WM, Silverstein B, Silverstein S. Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution 1% in the treatment of moderate to severe acute blepharitis/blepharoconjunctivitis. Curr Med Res Opin. 2011 Jan;27(1):171-8. doi: 10.1185/03007995.2010.539603. Epub 2010 Dec 7.

    PMID: 21138337DERIVED

MeSH Terms

Conditions

Blepharitis

Interventions

Tobramycin, Dexamethasone Drug CombinationAzithromycin

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

DexamethasonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedTobramycinNebramycinKanamycinAminoglycosidesGlycosidesCarbohydratesDrug CombinationsPharmaceutical PreparationsErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 13, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2010

Last Updated

June 11, 2012

Record last verified: 2011-01

Locations

US(1)