Ocular Hypertension
Conditions
Brief summary
Patient charts will be reviewed to evaluate the incidence of intraocular pressure spikes while on Loteprednol etabonate ophthalmic suspension 0.5%, Loteprednol etabonate (0.5%) and tobramycin (0.3%)
Interventions
DRUGLoteprednol etabonate ophthalmic suspension 0.5%
Apply one to two drops of Loteprednol etabonate ophthalmic suspension 0.5% into the conjunctival sac as prescribed by your physician
DRUGLoteprednol etabonate (0.5%) and tobramycin (0.3%).
Apply one or two drops of Loteprednol etabonate (0.5%) and tobramycin (0.3%) into the conjunctival sac as prescribed by your physician.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient who experienced an IOP spike while using Lotemax or Zylet will be included
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Elevated Intraocular Pressure (IOP) During Treatment | 55 days | Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol Etabonate Ophthalmic Suspension 0.5% Loteprednol etabonate ophthalmic suspension 0.5% | 43 |
| Loteprednol Etabonate (0.5%) and Tobramycin (0.3%) Loteprednol etabonate (0.5%) and tobramycin (0.3%) | 7 |
| Total | 50 |
Baseline characteristics
| Characteristic | Loteprednol Etabonate Ophthalmic Suspension 0.5% | Loteprednol Etabonate (0.5%) and Tobramycin (0.3%) | Total |
|---|---|---|---|
| Age Continuous | NA years | NA years | 58.8 years |
| Sex: Female, Male Female | NA Participants | NA Participants | — |
| Sex: Female, Male Male | NA Participants | NA Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 43 | 0 / 7 |
| serious Total, serious adverse events | 0 / 43 | 0 / 7 |
Outcome results
Primary
Mean Elevated Intraocular Pressure (IOP) During Treatment
Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days.
Time frame: 55 days
Population: Intent to treat, which included all patients in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol Etabonate Ophthalmic Suspension 0.5% | Mean Elevated Intraocular Pressure (IOP) During Treatment | 24.8 Millimeters of mercury (mmHg) | Standard Deviation 6.9 |
| Loteprednol Etabonate (0.5%) and Tobramycin (0.3%) | Mean Elevated Intraocular Pressure (IOP) During Treatment | 23.9 Millimeters of mercury (mmHg) | Standard Deviation 3.5 |