Intraocular Pressure With Loteprednol and Dexamethasone

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00781300
First received: October 27, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

October 27, 2008
October 27, 2008
March 2006
November 2006   (final data collection date for primary outcome measure)
Intraocular Pressure (IOP) [ Time Frame: Once a week for the first 4 weeks and 6 weeks after the procedure ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
IOP difference between the operated eye and the fellow eye [ Time Frame: Once a week for the first 4 weeks and then 6 weeks after the procedure ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intraocular Pressure With Loteprednol and Dexamethasone
A Randomized Clinical Trial Comparing the Intraocular Pressure Changes With the Use of Loteprednol and Dexamethasone After Pterygium Surgery

The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period.

Surgical management of pterygium is known to initiate an inflammatory process with different levels of intensity. Corticosteroids are anti-inflammatory agents used to reduce the inflammatory process observed after surgical interventions including after pterygium surgery. However, use of topical corticosteroids can induce an elevation in intraocular pressure (IOP) due to a reduction in the facility of aqueous outflow.

Loteprednol etabonate (LE) was designed to maintain the anti-inflammatory efficiency of corticosteroids while lowering the risk of inducing IOP elevation. LE showed less effect on IOP than Prednisolone Acetate. This probably occurs due to lower levels of LE in the aqueous humor.

Some trials compare LE to other corticosteroids or placebo in treatments of the anterior uveitis, allergic conjunctivitis and cataract surgery. To our knowledge, there are no trials studying the effect of LE on IOP after pterygium surgery.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glaucoma, Open-Angle
  • Ocular Hypertension
  • Drug: Loteprednol Etabonate 0.5%
    Patients in the Loteprednol Group received Loteprednol Etabonate 0.5% associated with Tobramycin 0.3% in separate eyedrops for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week
    Other Names:
    • Loteprol
    • Lotemax
  • Drug: Dexamethasone 0.1%
    The patients in Dexamethasone Group received Dexamethasone 0.1% associated with Tobramycin 0.3% in a single eyedrop for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week.
    Other Name: Tobradex
  • Active Comparator: Loteprednol
    Intervention: Drug: Loteprednol Etabonate 0.5%
  • Active Comparator: Dexamethasone
    Intervention: Drug: Dexamethasone 0.1%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
February 2007
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: eighteen years old or more
  • IOP: less than 22mmHg

Exclusion Criteria:

  • History of previous ocular surgery
  • Use of topical or systemic corticosteroids for up to a month before the surgery
  • Extensive pterygia that disabled accurate IOP measurement
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00781300
CEP 1104/03
No
Luciano Moreira Pinto, MD, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: Luciano M Pinto, MD Fedreal University of São Paulo
Federal University of São Paulo
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP