Conjunctivitis, Keratitis, Blepharitis
Conditions
Keywords
Blepharokeratoconjunctivitis
Brief summary
This study is to evaluate the safety and efficacy of loteprednol etabonate \[LE\] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).
Interventions
DRUGLoteprednol and tobramycin
Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have a clinical diagnosis of BKC in at least one eye * Subjects must be willing to discontinue contact lens use for the duration of the study * Subjects who are able and willing to comply with all treatment and follow- up/study procedures.
Exclusion criteria
* Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation. * Subjects who have any uncontrolled systemic disease or debilitating disease. * Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids. * Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1. * Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug. * Subjects having ocular surgery (including laser surgery) in either eye within the past three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population | Baseline, Day 15 | The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population | Baseline, Day 15 | The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population |
| Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population | Baseline, Day 8 | The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. |
| Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population | Baseline, Day 8 | The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population |
| Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population | Baseline, Day 3 | The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population. |
| Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population | Baseline, Day 3 | The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population. |
Countries
Singapore
Participant flow
Recruitment details
This study was conducted at seven sites, by seven Investigators in the People's Republic of China. First participant was enrolled 10/21/2009 and last participant visit was 2/9/2010.
Pre-assignment details
A total of 357 participants with clinically diagnosed blepharokeratoconjunctivitis (BKC) in at least one eye were enrolled. 328 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol and Tobramycin Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days. | 180 |
| Tobramycin and Dexamethasone Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days. | 177 |
| Total | 357 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 7 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Protocol Violation | 3 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Loteprednol and Tobramycin | Tobramycin and Dexamethasone | Total |
|---|---|---|---|
| Age Continuous | 40.8 Years STANDARD_DEVIATION 13.63 | 41.72 Years STANDARD_DEVIATION 13.54 | 41.26 Years STANDARD_DEVIATION 13.57 |
| Region of Enrollment Singapore | 180 participants | 177 participants | 357 participants |
| Sex: Female, Male Female | 123 Participants | 113 Participants | 236 Participants |
| Sex: Female, Male Male | 57 Participants | 64 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 177 | 36 / 177 |
| serious Total, serious adverse events | 0 / 177 | 0 / 177 |
Outcome results
Primary
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).
Time frame: Baseline, Day 15
Population: The PP population was the population used for the primary efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol and Tobramycin | Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population | -11.63 Scores on a scale | Standard Deviation 4.56 |
| Tobramycin and Dexamethasone | Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population | -12.41 Scores on a scale | Standard Deviation 4.71 |
Secondary
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population
Time frame: Baseline, Day 15
Population: The ITT population was used in this secondary efficacy parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol and Tobramycin | Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population | -11.64 Score on a scale | Standard Deviation 4.55 |
| Tobramycin and Dexamethasone | Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population | -11.98 Score on a scale | Standard Deviation 4.95 |
Secondary
Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.
Time frame: Baseline, Day 3
Population: The ITT population was used for this secondary efficacy parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol and Tobramycin | Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population | -5.54 Score on a scale | Standard Deviation 3.48 |
| Tobramycin and Dexamethasone | Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population | -5.92 Score on a scale | Standard Deviation 3.69 |
Secondary
Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.
Time frame: Baseline, Day 3
Population: The PP population was used for this secondary efficacy parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol and Tobramycin | Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population | -5.66 Score on a scale | Standard Deviation 3.46 |
| Tobramycin and Dexamethasone | Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population | -5.98 Score on a scale | Standard Deviation 3.68 |
Secondary
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population
Time frame: Baseline, Day 8
Population: The ITT population was used in this secondary efficacy parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol and Tobramycin | Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population | -8.91 Score on a scale | Standard Deviation 4.24 |
| Tobramycin and Dexamethasone | Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population | -9.96 Score on a scale | Standard Deviation 4.27 |
Secondary
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.
Time frame: Baseline, Day 8
Population: The PP population was used for this secondary efficacy parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol and Tobramycin | Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population | -9.20 Score on a scale | Standard Deviation 3.94 |
| Tobramycin and Dexamethasone | Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population | -10.21 Score on a scale | Standard Deviation 4.23 |