A Retrospective Evaluation of the Intraocular Pressure Spikes With Loteprednol and Loteprednol/Tobramycin

Completed

• Conditions: Ocular Hypertension
• Interventions: Drug: Loteprednol etabonate (0.5%) and tobramycin (0.3%).; Drug: Loteprednol etabonate ophthalmic suspension 0.5%

• Registration Number: NCT00834171
• Lead Sponsor: Allergan

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%)

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-03
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-08
• Results First Submitted: 2011-08-17
• Results First Submitted QC: 2011-08-17
• Last Update Submitted: 2011-08-17
• Results First Posted: 2011-09-26
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Any patient who experienced an IOP spike while using Lotemax or Zylet will be included

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Loteprednol etabonate (0.5%) and tobramycin (0.3%).	Loteprednol etabonate (0.5%) and tobramycin (0.3%)
1	Loteprednol etabonate ophthalmic suspension 0.5%	Loteprednol etabonate ophthalmic suspension 0.5%

Primary Outcome Measures

Name	Time	Method
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.