Ocular Inflammation
Conditions
Brief summary
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.
Interventions
Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.
DRUGVehicle of Ophthalmic Loteprednol Etabonate
Vehicle of ophthalmic loteprednol etabonate administered postoperatively 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
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects at least 18 years of age * Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization. * Subjects who are candidate for routine, uncomplicated cataract surgery. * Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening. * Subjects must be willing and able to comply with all treatment and follow- up procedures.
Exclusion criteria
* Subjects who have known hypersensitivity or contraindication to the study drug or its components. * Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study. * Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up. * Subjects with elevated intraocular pressure (\>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye. * Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye. * Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit. * Women who are pregnant or breast feeding. * Subjects who have participated in an investigational drug or device study within the last 30 days. * Subjects previously randomized in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 | Postoperative day 8 (Visit 5) | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. |
| Participants With Grade 0 (no) Pain | Postoperative day 8 (Visit 5) | Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | At each visit: Visit 4-7, postoperative days 3-18 | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. |
| Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Postoperative Day 3-18 (Each follow-up Visit 4-7) | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 16 sites in the US. The first participant was enrolled June 20, 2008 and the last participant visit was May 1, 2009.
Pre-assignment details
405 participants, who were candidates for routine, uncomplicated cataract surgery were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol Etabonate Loteprednol Etabonate Ophthalmic Ointment 0.5% | 203 |
| Vehicle Vehicle of Ophthalmic Loteprednol Etabonate | 202 |
| Total | 405 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Travel Problem | 1 | 0 |
Baseline characteristics
| Characteristic | Loteprednol Etabonate | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 9.13 | 69.2 years STANDARD_DEVIATION 9.36 | 68.8 years STANDARD_DEVIATION 9.24 |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 5 participants | 6 participants | 11 participants |
| Race/Ethnicity, Customized Black/African American | 13 participants | 16 participants | 29 participants |
| Race/Ethnicity, Customized Native Hawiian/Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White | 182 participants | 178 participants | 360 participants |
| Sex: Female, Male Female | 115 Participants | 115 Participants | 230 Participants |
| Sex: Female, Male Male | 88 Participants | 87 Participants | 175 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 81 / 204 | 151 / 201 |
| serious Total, serious adverse events | 2 / 204 | 4 / 201 |
Outcome results
Primary
Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Time frame: Postoperative day 8 (Visit 5)
Population: Intent to treat population, subjects who had missing data or took rescue medication prior to visit 5 were imputed as no.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loteprednol Etabonate | Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 | 64 participants |
| Vehicle | Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 | 23 participants |
Primary
Participants With Grade 0 (no) Pain
Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe
Time frame: Postoperative day 8 (Visit 5)
Population: Intent to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loteprednol Etabonate | Participants With Grade 0 (no) Pain | 149 participants |
| Vehicle | Participants With Grade 0 (no) Pain | 83 participants |
Secondary
Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Time frame: Postoperative Day 3-18 (Each follow-up Visit 4-7)
Population: Intent to treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loteprednol Etabonate | Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 4, postoperative day 3 | -1.2 Composite scores | Standard Deviation 1.2 |
| Loteprednol Etabonate | Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 5, postoperative day 8 | -2.2 Composite scores | Standard Deviation 1.51 |
| Loteprednol Etabonate | Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 6, postoperative day 15 | -2.7 Composite scores | Standard Deviation 1.58 |
| Loteprednol Etabonate | Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 7, postoperative day 18 | -2.6 Composite scores | Standard Deviation 1.59 |
| Vehicle | Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 7, postoperative day 18 | -1.1 Composite scores | Standard Deviation 2.01 |
| Vehicle | Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 4, postoperative day 3 | -0.6 Composite scores | Standard Deviation 1.48 |
| Vehicle | Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 6, postoperative day 15 | -1.1 Composite scores | Standard Deviation 1.94 |
| Vehicle | Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 5, postoperative day 8 | -0.8 Composite scores | Standard Deviation 1.81 |
Secondary
Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Time frame: At each visit: Visit 4-7, postoperative days 3-18
Population: Intent to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loteprednol Etabonate | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Visit 4, postoperative day 3 | 10 participants |
| Loteprednol Etabonate | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Visit 5, postoperative day 8 | 64 participants |
| Loteprednol Etabonate | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Visit 6, posoperative day 15 | 107 participants |
| Loteprednol Etabonate | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Visit 7, postoperative day 18 | 100 participants |
| Vehicle | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Visit 7, postoperative day 18 | 46 participants |
| Vehicle | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Visit 4, postoperative day 3 | 9 participants |
| Vehicle | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Visit 6, posoperative day 15 | 42 participants |
| Vehicle | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Visit 5, postoperative day 8 | 23 participants |