search
Back to results

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

Primary Purpose

Cataract Extraction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acular LS
Lotemax
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Extraction focused on measuring cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Storm Eye Institute, Medical University of South Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 17, 2006
Last Updated
June 13, 2018
Sponsor
Medical University of South Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT00366691
Brief Title
Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation
Official Title
Comparison of Acular LS With Lotemax to Prevent Anterior Segment Inflammation After Phacoemulsification and Intraocular Lens Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of South Carolina

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Extraction
Keywords
cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Acular LS
Intervention Type
Drug
Intervention Name(s)
Lotemax

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry D Solomon, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Storm Eye Institute, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs