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OpenTrials
Completed

NCT Number: NCT01384266

A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery

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.

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Key information

Conditions

Intraocular Inflammation Eye Diseases Uveal Diseases Uveitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Eye Institute, Edgewood, Kentucky, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intraocular inflammation grading

    Time frame: Day 21 Post-op

    Slit Lamp examination will be done at each visit to grade intraocular inflammation

Secondary outcomes

  1. Intraocular pressure spikes

    Time frame: Day 21 post-op

    Intraocular pressure(IOP) will be measured at each visit.

Sponsors and collaborators

Lead sponsor

Associated Eye Care, Minnesota

Other

Collaborators

  • Bausch & Lomb Incorporated

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 29, 2011
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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