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

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%)

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Key information

Conditions

Ocular Hypertension Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maclean, Virginia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Loteprednol etabonate ophthalmic suspension 0.5%

Drug

Apply one to two drops of Loteprednol etabonate ophthalmic suspension 0.5% into the conjunctival sac as prescribed by your physician

Other names: LOTEMAX®

Loteprednol etabonate (0.5%) and tobramycin (0.3%).

Drug

Apply one or two drops of Loteprednol etabonate (0.5%) and tobramycin (0.3%) into the conjunctival sac as prescribed by your physician.

Other names: Zylet®

Primary outcomes

Mean Elevated Intraocular Pressure (IOP) During Treatment

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Feb 3, 2009
Registry last updated: Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed