Ocular Inflammation
Conditions
Brief summary
To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery
Interventions
DRUG0.5% Loteprednol Etabonate Ophthalmic Ointment
1/2 inch ribbon four times a day for 14 days
DRUGVehicle of Loteprednol Etabonate Ophthalmic Ointment
1/2 inch ribbon four times a day 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
1. Subjects who are candidate for routine, uncomplicated cataract surgery 2. Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.
Exclusion criteria
1. Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids 2. Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components 3. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye 4. Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects 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. |
| Grade 0 for 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 |
|---|---|---|
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | At each follow-up visit through day18 (Visit 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. |
| Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Baseline and each follow-up visit through day18 (Visit 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
A total of 400 subjects, 18 years old or older who were candidates for routine, uncomplicated cataract surgery, were enrolled at 17 investigative sites in the US. First subject was enrolled on 3/14/2008 and last subject visit was 3/23/2009.
Pre-assignment details
Following cataract surgery at visit 3 (post operative day 1), subjects were assessed for eligibility. 201 subjects were randomized to receive loteprednol etabonate ointment and 199 to receive its vehicle.
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol Etabonate Loteprednol etabonate 0.5% ophthalmic ointment | 201 |
| Vehicle Vehicle of loteprednol etabonate ointment | 199 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Loteprednol Etabonate | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 9.39 | 69.2 years STANDARD_DEVIATION 8.77 | 69.2 years STANDARD_DEVIATION 9.08 |
| Race/Ethnicity, Customized Asian | 1 participants | 6 participants | 7 participants |
| Race/Ethnicity, Customized Black or African American | 17 participants | 12 participants | 29 participants |
| Race/Ethnicity, Customized Other | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized White | 183 participants | 179 participants | 362 participants |
| Sex: Female, Male Female | 118 Participants | 119 Participants | 237 Participants |
| Sex: Female, Male Male | 83 Participants | 80 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 110 / 201 | 161 / 199 |
| serious Total, serious adverse events | 3 / 201 | 2 / 199 |
Outcome results
Primary
Grade 0 for 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 | Group | Value (NUMBER) |
|---|---|---|---|
| Loteprednol Etabonate | Grade 0 for Pain | No | 45 participants |
| Loteprednol Etabonate | Grade 0 for Pain | Yes | 156 participants |
| Vehicle | Grade 0 for Pain | Yes | 90 participants |
| Vehicle | Grade 0 for Pain | No | 109 participants |
Primary
Subjects 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loteprednol Etabonate | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. | Yes | 48 participants |
| Loteprednol Etabonate | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. | No | 153 participants |
| Vehicle | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. | Yes | 27 participants |
| Vehicle | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. | No | 172 participants |
Secondary
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: Baseline and each follow-up visit through day18 (Visit 7)
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loteprednol Etabonate | Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 4 (postoperative day 3) | -1.0 Composit scores | Standard Deviation 1.08 |
| Loteprednol Etabonate | Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 5 (postoperative day 8) | -2.1 Composit scores | Standard Deviation 1.31 |
| Loteprednol Etabonate | Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 6 (postoperative day 15) | -2.6 Composit scores | Standard Deviation 1.37 |
| Loteprednol Etabonate | Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 7 (postoperative day 18) | -2.5 Composit scores | Standard Deviation 1.45 |
| Vehicle | Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 7 (postoperative day 18) | -1.1 Composit scores | Standard Deviation 1.95 |
| Vehicle | Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 4 (postoperative day 3) | -0.4 Composit scores | Standard Deviation 1.42 |
| Vehicle | Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 6 (postoperative day 15) | -0.9 Composit scores | Standard Deviation 1.97 |
| Vehicle | Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Visit 5 (postoperative day 8) | -0.7 Composit scores | Standard Deviation 1.81 |
Secondary
Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up 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 follow-up visit through day18 (Visit 7)
Population: Intent to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loteprednol Etabonate | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Visit 4 (postoperative day 3) | 10 participants |
| Loteprednol Etabonate | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Visit 5 (postoperative day 8) | 48 participants |
| Loteprednol Etabonate | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Visit 6 (postoperative day 15) | 84 participants |
| Loteprednol Etabonate | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Visit 7 (postoperative day 18) | 86 participants |
| Vehicle | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Visit 7 (postoperative day 18) | 39 participants |
| Vehicle | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Visit 4 (postoperative day 3) | 9 participants |
| Vehicle | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Visit 6 (postoperative day 15) | 30 participants |
| Vehicle | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Visit 5 (postoperative day 8) | 27 participants |