Status:
COMPLETED
Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cataract Extraction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 no...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00366691
Start Date
February 1 2006
End Date
September 1 2007
Last Update
June 14 2018
Active Locations (1)
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1
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, United States, 29425