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

NCT00366691 | Completed Phase 4

• 1 other identifier: MRC-06-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Extraction

Keywords

cataract

Interventions

Acular LS DRUG

Lotemax DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have a visually significant age-related cataract, in the planned operated eye.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Storm Eye Institute, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Ketorolac; Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kerry D Solomon, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2006
• First Posted: August 21, 2006
• Study Start: February 1, 2006
• Study Completion: September 1, 2007
• Last Updated: June 14, 2018

Record last verified: 2006-06

Locations

US (1)