Inflammation, Pain
Conditions
Brief summary
This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
Interventions
Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.
Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.
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 who are at least 18 years of age. * Subjects who are candidates for routine, uncomplicated cataract surgery.
Exclusion criteria
* Subjects who have known hypersensitivity or contraindication to the study drug or components. * Subjects with 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 (\>/=21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye. * Subjects who are monocular or have pinholed Snellen visual acuity (VA) 20/200 or worse in the non-study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Anterior Chamber Cells. | Visit 5 (Postoperative day 8) | Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells |
| Grade 0 Pain | Visit 5 (Postoperative day 8) | Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Anterior Chamber Cells | Visit 4-7 (postoperative day 3-18) | Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells |
| Grade 0 Pain | Visits 4-7 (Postoperative days 3-18) | Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain |
| Resolution of Anterior Chamber Flare | Visit 4-7 (postoperative day 3-18) | Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 22 enrolling sites; 2 in the European Union (EU) and 20 in the United States (US). First participant was enrolled on 2/19/2010 and last participant completed the study on 9/3/2010.
Pre-assignment details
A total of 407 participants, who were candidates for routine, uncomplicated cataract surgery, were enrolled in the study, 400 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol Etabonate Loteprednol etabonate 0.5% ophthalmic suspension | 206 |
| Vehicle Vehicle of loteprednol etabonate ophthalmic suspension. | 201 |
| Total | 407 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Acute cholecystitis | 1 | 0 |
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Excluded Medications | 0 | 1 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Loteprednol Etabonate | Vehicle | Total |
|---|---|---|---|
| Age Continuous | 68.3 years STANDARD_DEVIATION 9.66 | 69.4 years STANDARD_DEVIATION 9.56 | 68.9 years STANDARD_DEVIATION 9.62 |
| Region of Enrollment Germany | 8 participants | 8 participants | 16 participants |
| Region of Enrollment United States | 198 participants | 193 participants | 391 participants |
| Sex: Female, Male Female | 124 Participants | 109 Participants | 233 Participants |
| Sex: Female, Male Male | 82 Participants | 92 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 206 | 24 / 201 |
| serious Total, serious adverse events | 3 / 206 | 1 / 201 |
Outcome results
Primary
Grade 0 Pain
Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain
Time frame: Visit 5 (Postoperative day 8)
Population: Intention to treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loteprednol Etabonate | Grade 0 Pain | 156 participants |
| Vehicle | Grade 0 Pain | 92 participants |
Primary
Resolution of Anterior Chamber Cells.
Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Time frame: Visit 5 (Postoperative day 8)
Population: Intention to treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loteprednol Etabonate | Resolution of Anterior Chamber Cells. | 64 participants |
| Vehicle | Resolution of Anterior Chamber Cells. | 28 participants |
Secondary
Grade 0 Pain
Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain
Time frame: Visits 4-7 (Postoperative days 3-18)
Population: Intention to treat population (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loteprednol Etabonate | Grade 0 Pain | Visit 7 (Postoperative Day 18) | 151 participants |
| Loteprednol Etabonate | Grade 0 Pain | Visit 4 (Postoperative Day 3) | 139 participants |
| Loteprednol Etabonate | Grade 0 Pain | Visit 5 (Postoperative Day 8) | 156 participants |
| Loteprednol Etabonate | Grade 0 Pain | Visit 6 (Postoperative Day 15) | 160 participants |
| Vehicle | Grade 0 Pain | Visit 6 (Postoperative Day 15) | 89 participants |
| Vehicle | Grade 0 Pain | Visit 7 (Postoperative Day 18) | 79 participants |
| Vehicle | Grade 0 Pain | Visit 5 (Postoperative Day 8) | 92 participants |
| Vehicle | Grade 0 Pain | Visit 4 (Postoperative Day 3) | 93 participants |
Secondary
Resolution of Anterior Chamber Cells
Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Time frame: Visit 4-7 (postoperative day 3-18)
Population: Intention to treat population (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loteprednol Etabonate | Resolution of Anterior Chamber Cells | Visit 4 (Postoperative Day 3) | 8 participants |
| Loteprednol Etabonate | Resolution of Anterior Chamber Cells | Visit 5 (Postoperative Day 8) | 64 participants |
| Loteprednol Etabonate | Resolution of Anterior Chamber Cells | Visit 6 (Postoperative Day 15) | 116 participants |
| Loteprednol Etabonate | Resolution of Anterior Chamber Cells | Visit 7 (Postoperative Day 18) | 114 participants |
| Vehicle | Resolution of Anterior Chamber Cells | Visit 7 (Postoperative Day 18) | 59 participants |
| Vehicle | Resolution of Anterior Chamber Cells | Visit 4 (Postoperative Day 3) | 7 participants |
| Vehicle | Resolution of Anterior Chamber Cells | Visit 6 (Postoperative Day 15) | 61 participants |
| Vehicle | Resolution of Anterior Chamber Cells | Visit 5 (Postoperative Day 8) | 28 participants |
Secondary
Resolution of Anterior Chamber Flare
Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.
Time frame: Visit 4-7 (postoperative day 3-18)
Population: Intention to treat population (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loteprednol Etabonate | Resolution of Anterior Chamber Flare | Visit 4 (Postoperative Day 3) | 93 participants |
| Loteprednol Etabonate | Resolution of Anterior Chamber Flare | Visit 5 (Postoperative Day 8) | 134 participants |
| Loteprednol Etabonate | Resolution of Anterior Chamber Flare | Visit 6 (Postoperative Day 15) | 162 participants |
| Loteprednol Etabonate | Resolution of Anterior Chamber Flare | Visit 7 (Postoperative Day 18) | 143 participants |
| Vehicle | Resolution of Anterior Chamber Flare | Visit 7 (Postoperative Day 18) | 75 participants |
| Vehicle | Resolution of Anterior Chamber Flare | Visit 4 (Postoperative Day 3) | 64 participants |
| Vehicle | Resolution of Anterior Chamber Flare | Visit 6 (Postoperative Day 15) | 90 participants |
| Vehicle | Resolution of Anterior Chamber Flare | Visit 5 (Postoperative Day 8) | 72 participants |