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

NCT00834171 | Completed Results

• 1 other identifier: MA-RES-08-003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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%)

Conditions

Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Elevated Intraocular Pressure (IOP) During Treatment

  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.

  55 days

Study Arms (2)

1

Loteprednol etabonate ophthalmic suspension 0.5%

Drug: Loteprednol etabonate ophthalmic suspension 0.5%

2

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

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

Interventions

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

Also known as: LOTEMAX®

1

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.

Also known as: Zylet®

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Maclean, Virginia, United States

Location

MeSH Terms

Conditions

Ocular Hypertension

Interventions

Loteprednol Etabonate; Tobramycin

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Vice President Medical Affairs
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 26, 2011
• Results First Posted: September 26, 2011

Record last verified: 2011-08

Locations

US (1)