Conjunctivitis
Conditions
Keywords
Blepharokeratoconjunctivitis
Brief summary
The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.
Interventions
DRUGloteprednol etabonate and tobramycin
Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
DRUGTobramycin
Topical ocular administration of Tobramycin QID for 14 days.
DRUGVehicle of Zylet
Topical ocular administration of the vehicle of Zylet QID for 14 days.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 6 Years
Healthy volunteers
No
Inclusion criteria
* children 0-6 years of age. * clinical diagnosis of blepharoconjunctivitis * Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures. * Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.
Exclusion criteria
* Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication. * Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months. * Subjects who are monocular. * Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study. * Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total Blepharoconjunctivitis Grade. | Baseline to 15 days | Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2 | Baseline to Day 3 | Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. |
| Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3 | Baseline to Day 7 | Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 17 sites in the United States. First participant was enrolled on 6/26/2008 and last participant visit was 3/24/2010.
Pre-assignment details
A total of 137 pediatric subjects, 0 to 6 years of age, of either gender and any race, who had a clinical diagnosis of blepharoconjunctivitis in at least one eye were randomized in this study. 126 Participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol Etabonate and Tobramycin Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID). | 34 |
| Loteprednol Etabonate Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID). | 35 |
| Tobramycin Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID). | 34 |
| Vehicle Vehicle of Zylet. One or two drops in study eye four times a day (QID). | 34 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 3 | 2 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Screen Failure | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Loteprednol Etabonate and Tobramycin | Loteprednol Etabonate | Tobramycin | Vehicle | Total |
|---|---|---|---|---|---|
| Age, Customized 0-6 years | 34 participants | 35 participants | 34 participants | 34 participants | 137 participants |
| Region of Enrollment United States | 34 participants | 35 participants | 34 participants | 34 participants | 137 participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 15 Participants | 14 Participants | 57 Participants |
| Sex: Female, Male Male | 24 Participants | 17 Participants | 19 Participants | 20 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 34 | 2 / 35 | 2 / 34 | 2 / 33 |
| serious Total, serious adverse events | 2 / 34 | 2 / 35 | 2 / 34 | 1 / 33 |
Outcome results
Primary
Change From Baseline in the Total Blepharoconjunctivitis Grade.
Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Time frame: Baseline to 15 days
Population: Study eye, ITT Population, Non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol Etabonate and Tobramycin | Change From Baseline in the Total Blepharoconjunctivitis Grade. | -11.41 Score on a scale | Standard Deviation 3.29 |
| Loteprednol Etabonate | Change From Baseline in the Total Blepharoconjunctivitis Grade. | -11.23 Score on a scale | Standard Deviation 3.98 |
| Tobramycin | Change From Baseline in the Total Blepharoconjunctivitis Grade. | -10.68 Score on a scale | Standard Deviation 4.71 |
| Vehicle | Change From Baseline in the Total Blepharoconjunctivitis Grade. | -10.30 Score on a scale | Standard Deviation 5.19 |
Secondary
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Time frame: Baseline to Day 3
Population: Study eye, ITT population, non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol Etabonate and Tobramycin | Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2 | -7.32 Score on a scale | Standard Deviation 3.27 |
| Loteprednol Etabonate | Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2 | -7.74 Score on a scale | Standard Deviation 3.9 |
| Tobramycin | Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2 | -5.94 Score on a scale | Standard Deviation 4 |
| Vehicle | Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2 | -6.58 Score on a scale | Standard Deviation 3.46 |
Secondary
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3
Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Time frame: Baseline to Day 7
Population: Study eye ITT population, subjects with non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol Etabonate and Tobramycin | Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3 | -11.03 Score on a scale | Standard Deviation 3.2 |
| Loteprednol Etabonate | Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3 | -10.94 Score on a scale | Standard Deviation 4.69 |
| Tobramycin | Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3 | -9.90 Score on a scale | Standard Deviation 3.8 |
| Vehicle | Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3 | -10.03 Score on a scale | Standard Deviation 4.63 |