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

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ClinicalTrials.gov Identifier: NCT00834171
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : September 26, 2011
Last Update Posted : September 26, 2011
Sponsor:
Information provided by:
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%)

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

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other Name: LOTEMAX®

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.
Other Name: Zylet®




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834171


Locations
United States, Virginia
Maclean, Virginia, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Vice President Medical Affairs, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00834171     History of Changes
Other Study ID Numbers: MA-RES-08-003
First Posted: February 3, 2009    Key Record Dates
Results First Posted: September 26, 2011
Last Update Posted: September 26, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Tobramycin
Loteprednol Etabonate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Allergic Agents