A Randomized, Multicenter, Masked Evaluation of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate for the Treatment of Inflammation Following Cataract Surgery

Associated Eye Care, Minnesota2 sites in 1 country90 target enrollmentMay 2010

ConditionsIntraocular Inflammation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intraocular Inflammation
Sponsor: Associated Eye Care, Minnesota
Enrollment: 90
Locations: 2
Primary Endpoint: Intraocular inflammation grading
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Patients are routinely given steroid eye drops following cataract surgery. This study will compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used following cataract surgery. Patients will be randomly assigned to one drop or the other, and evaluated for inflammation and intraocular pressure as part of the comparison. The study Doctor will be masked as to which drop the patient receives to avoid bias.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

November 2011

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Associated Eye Care, Minnesota

Responsible Party

Principal Investigator

Stephen S. Lane, MD

Prinicipal Investigator

Associated Eye Care, Minnesota

Eligibility Criteria

Inclusion Criteria

•Subjects age 18 and older undergoing routine cataract surgery.

Exclusion Criteria

•Subjects being treated for elevated intraocular pressure, retinopathy, maculopathy, cornea or vitreous opacities that would interfere with visual acuity.
•Subjects with diabetes, pseudoexfoliation, uveitis, corneal endothelial disease, or active Herpes Simplex Virus(HSV) or Herpes Zoster Virus(HZV) Pupil Stretch and/or Limbal Relaxing Incision(LRIs) will be allowed.
•Subjects with previous ocular trauma or intraocular surgery
•Subjects with sensitivities to steroids.
•Women who are not post-menopausal or are of child bearing potential will be excluded.
•Intraoperative complications during surgery including posterior capsule rupture and vitreous loss
•Subjects with best visual potential in the fellow eye worse than 20/60
•Subjects who are expected to require concurrent ocular or systemic therapy with non-steroidal anti-inflammatory drugs (NSAIDS) mast cell stabilizers, antihistamines, or decongestants within 2 days prior to or during the 21 days following surgery. (Intraoperative NSAIDS for mydriasis are permitted.) 325 mg Aspirin is permitted.
•Subjects who are expected to require concurrent ocular or systemic corticosteroids, immunosuppressants (including Restasis) within 14 days prior to or 21 days following surgery