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Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00366691
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : June 14, 2018
Sponsor:
Information provided by:
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE August 17, 2006
First Posted Date  ICMJE August 21, 2006
Last Update Posted Date June 14, 2018
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation
Official Title  ICMJE Comparison of Acular LS With Lotemax to Prevent Anterior Segment Inflammation After Phacoemulsification and Intraocular Lens Implantation
Brief Summary The purpose of this study is to compare the effectiveness of Acular LS® and Lotemax® in the prevention of inflammation in the eye after cataract surgery. Acular LS is made by Allergan, Inc. It is a nonsteroidal anti-inflammatory drug (NSAID) and is approved by the Food and Drug Administration (FDA) for use following cataract surgery. Lotemax is made by Bausch & Lomb. It is a steroid and is also approved by the FDA for use following cataract surgery.
Detailed Description

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAIDs) which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis (cyclo-oxigenase inhibitors). However, they leave the lipoxygenase pathway free to generate leukotrienes. This pharmacodynamic activity has been speculated as a reason why NSAIDs produce less ocular side effects than corticosteroids. It has been widely used in ophthalmology. In 1987, Flach1 published its effectiveness in the treatment of aphakic and pseudophakic macular edema. Its efficacy after cataract surgery has been shown2 and it has been compared to topical steroids after extra-capsular cataract extraction3,4,5 and phacoemulsification6,7. It has been used as analgesic after radial keratotomy(RK)8,9, photorefractive keratectomy (PRK)10 and laser in situ keratomileusis (LASIK)11

The purpose of this study is to compare the effectiveness of the NSAID ketorolac tromethamine ophthalmic solution 0.4% with the steroid loteprednol etabonate ophthalmic suspension 0.5% for preventing anterior segment inflammation after routine cataract surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cataract Extraction
Intervention  ICMJE
  • Drug: Acular LS
  • Drug: Lotemax
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August¬†18,¬†2006)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must have a visually significant age-related cataract, in the planned operated eye.
  • 18 years of age or older.
  • The vision in the fellow, unoperated eye should have a potential visual acuity of 20/40 or better as determined by the principal investigator.
  • Patient must desire cataract extraction.
  • Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

  • Advanced glaucomatous damage.
  • Any abnormality preventing reliable applanation tonometry in operated eye.
  • Contact lens use during the active treatment portion of the trial in the operated eye.
  • Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye.
  • Any history of allergic hypersensitivity or poor tolerance to any component of the preparations used in this trial.
  • Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
  • Any clinically significant, serious or severe medical or psychiatric condition.
  • Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
  • Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
  • Required use of other topical medications during the active portion of the trial except prophylactic antibiotic, topical lid care, tear replacement solutions or glaucoma medications.
  • Other ocular surgery at the time of the cataract extraction.
  • Use of topical or oral antiprostaglandins or corticosteroids as well as aspirin products (> 81 mg) during the active treatment portion of the trial. If patient wants to participate in the trial and can stop the medication, he/she can be enrolled after 7-day wash out period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366691
Other Study ID Numbers  ICMJE MRC-06-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medical University of South Carolina
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kerry D Solomon, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date June 2006

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