Ocular Inflammation Associated With Blepharaconjunctivitis
Conditions
Keywords
Ocular inflammation, blepharaconjunctivitis
Brief summary
The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis
Interventions
DRUGTobramycin 0.3%/Dexamethasone 0.05%
Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days
DRUGTOBRADEX
TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ocular inflammation associated with blepharaconjunctivitis
Exclusion criteria
* ocular allergy * ocular disorders that would preclude safe administration of test article
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4) | Day 4 - Test Of Cure (TOC) compared to Day 0 | Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria. |
Countries
United States
Participant flow
Recruitment details
20 enrolling sites (private ophthalmology clinical offices) with first subject enrolled 10/29/07 and last subject enrolled 2/14/08)
Pre-assignment details
Parallel, 1:1 ratio; double-masked
Participants by arm
| Arm | Count |
|---|---|
| Tobramycin 0.3%/Dexamethasone 0.05% Tobramycin 0.3%/Dexamethasone 0.05% | 109 |
| TOBRADEX Ophthalmic Suspension TOBRADEX Ophthalmic Suspension | 112 |
| Total | 221 |
Baseline characteristics
| Characteristic | Tobramycin 0.3%/Dexamethasone 0.05% | TOBRADEX Ophthalmic Suspension | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Categorical >=65 years | 40 Participants | 48 Participants | 88 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 62 Participants | 127 Participants |
| Sex: Female, Male Female | 53 Participants | 65 Participants | 118 Participants |
| Sex: Female, Male Male | 56 Participants | 47 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 109 | 0 / 112 |
| serious Total, serious adverse events | 0 / 109 | 0 / 112 |
Outcome results
Primary
Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.
Time frame: Day 4 - Test Of Cure (TOC) compared to Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tobramycin 0.3%/Dexamethasone 0.05% | Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4) | 100.0 Percent of patients |
| TOBRADEX Ophthalmic Suspension | Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4) | 94.4 Percent of patients |