A Retrospective Evaluation of the Intraocular Pressure Spikes With Loteprednol and Loteprednol/Tobramycin - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00834171

Purpose

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%)

Condition	Intervention
Ocular Hypertension	Drug: Loteprednol etabonate ophthalmic suspension 0.5% Drug: Loteprednol etabonate (0.5%) and tobramycin (0.3%).

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Tobramycin Tobramycin sulfate Loteprednol etabonate Loteprednol

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective

Further study details as provided by Allergan:

Primary Outcome Measures:

Elevation of intraocular pressure [ Time Frame: Any time point the incidence of IOP occured ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Loteprednol etabonate ophthalmic suspension 0.5%	Drug: Loteprednol 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
2 Loteprednol etabonate (0.5%) and tobramycin (0.3%)	Drug: Loteprednol 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Data to be collected will include: Patient Demographics (age, gender, race, eye color), medical and ophthalmic history, active ophthalmic disease, active systemic diseases, concomitant medications, procedure/condition for which Lotemax/Zylet were prescribed, underlying etiology requiring PK (if applicable), history of prior ocular surgery, prior history of steroid response, history of glaucoma, start/stop date of steroid treatment, IOP before and after steroid treatment, treatment-related adverse events, and any other notes/information that the investigator feels may be important.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834171

Locations

United States, Virginia

Maclean, Virginia, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Vice President Medical Affairs )
Study ID Numbers:	MA-RES-08-003
Study First Received:	January 30, 2009
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00834171 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Bacterial Agents
Tobramycin
Eye Diseases
Vascular Diseases

Anti-Allergic Agents
Loteprednol etabonate
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Tobramycin
Therapeutic Uses
Eye Diseases
Vascular Diseases

Cardiovascular Diseases
Anti-Allergic Agents
Loteprednol etabonate
Pharmacologic Actions
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009