N/A
N=50
A Retrospective Evaluation of the Intraocular Pressure Spikes With Loteprednol and Loteprednol/Tobramycin
Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00834171 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Mean Elevated Intraocular Pressure (IOP) During Treatment — 24.8; 23.9 Millimeters of mercury (mmHg)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Loteprednol etabonate ophthalmic suspension 0.5% (Drug); Loteprednol etabonate (0.5%) and tobramycin (0.3%). (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Elevated Intraocular Pressure (IOP) During Treatment |
24.8; 23.9 | — |
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%)
Eligibility Criteria
Inclusion Criteria
- Any patient who experienced an IOP spike while using Lotemax or Zylet will be included
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT00834171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.