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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00834171
First received: January 30, 2009
Last updated: August 17, 2011
Last verified: August 2011
  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%).

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Mean Elevated Intraocular Pressure (IOP) During Treatment [ Time Frame: 55 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: January 2009
Study Completion Date: December 2009
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
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Vice President Medical Affairs, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00834171     History of Changes
Other Study ID Numbers: MA-RES-08-003
Study First Received: January 30, 2009
Results First Received: August 17, 2011
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Loteprednol etabonate
Tobramycin
Anti-Allergic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014