Inflammation, Pain
Conditions
Brief summary
This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
Interventions
1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 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 who are at least 18 years of age. * Subjects who are candidates for routine, uncomplicated cataract surgery. * 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
* 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 VA 20/200 or worse in the non-study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Anterior Chamber Cells (ACC). | Visit 5 (Postoperative day 8) | Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp. |
| Grade 0 Pain | Visit 5 (Postoperative Day 8) | Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Anterior Chamber Cells. | At visits 4-7- postoperative day 3, 8,15 & 18 | Study eyes with complete resolution of anterior chamber cells (ACC) |
Countries
United States
Participant flow
Recruitment details
This study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.
Pre-assignment details
406 participants eligible for cataract surgery were enrolled in the study (safety population). 397 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol Loteprednol etabonate 0.5% | 203 |
| Vehicle Vehicle of loteprednol etabonate | 203 |
| Total | 406 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Investigator decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Vehicle | Total | Loteprednol |
|---|---|---|---|
| Age Continuous | 69.0 years STANDARD_DEVIATION 9.8 | 69.1 years STANDARD_DEVIATION 9.27 | 69.3 years STANDARD_DEVIATION 8.73 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 5 participants | 2 participants |
| Race/Ethnicity, Customized Black or African American | 16 participants | 36 participants | 20 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Other | 1 participants | 5 participants | 4 participants |
| Race/Ethnicity, Customized White | 182 participants | 358 participants | 176 participants |
| Sex: Female, Male Female | 122 Participants | 231 Participants | 109 Participants |
| Sex: Female, Male Male | 81 Participants | 175 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 203 | 0 / 203 |
| serious Total, serious adverse events | 1 / 203 | 2 / 203 |
Outcome results
Primary
Grade 0 Pain
Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
Time frame: Visit 5 (Postoperative Day 8)
Population: Intent to treat population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loteprednol | Grade 0 Pain | 148 Eyes |
| Vehicle | Grade 0 Pain | 85 Eyes |
p-value: <0.00195% CI: [21.4, 40.7]Chi-squared
Primary
Resolution of Anterior Chamber Cells (ACC).
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Time frame: Visit 5 (Postoperative day 8)
Population: Intent to treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loteprednol | Resolution of Anterior Chamber Cells (ACC). | 62 Eyes |
| Vehicle | Resolution of Anterior Chamber Cells (ACC). | 33 Eyes |
p-value: <0.00195% CI: [5.7, 22.9]Chi-squared
Secondary
Resolution of Anterior Chamber Cells.
Study eyes with complete resolution of anterior chamber cells (ACC)
Time frame: At visits 4-7- postoperative day 3, 8,15 & 18
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loteprednol | Resolution of Anterior Chamber Cells. | Visit 4 | 17 Eyes |
| Loteprednol | Resolution of Anterior Chamber Cells. | Visit 6 | 102 Eyes |
| Loteprednol | Resolution of Anterior Chamber Cells. | Visit 5 | 62 Eyes |
| Loteprednol | Resolution of Anterior Chamber Cells. | Visit 7 | 96 Eyes |
| Vehicle | Resolution of Anterior Chamber Cells. | Visit 5 | 33 Eyes |
| Vehicle | Resolution of Anterior Chamber Cells. | Visit 4 | 11 Eyes |
| Vehicle | Resolution of Anterior Chamber Cells. | Visit 7 | 45 Eyes |
| Vehicle | Resolution of Anterior Chamber Cells. | Visit 6 | 44 Eyes |