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VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

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: NCT01515826
Recruitment Status : Withdrawn (Management decision)
First Posted : January 24, 2012
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE January 19, 2012
First Posted Date  ICMJE January 24, 2012
Last Update Posted Date March 26, 2014
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
  • Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber [ Time Frame: Day 15 post-operative ]
    As assessed by the investigator during slit-lamp examination.
  • Percentage of patients with no clinically evidenced bacterial infection [ Time Frame: Day 15 post-operative ]
    As assessed by the investigator during slit-lamp examination.
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
  • Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber [ Time Frame: Day 15 post-operative or upon study exit, if earlier ]
    As assessed by the investigator during slit-lamp examination.
  • Percentage of patients with no clinically evidenced bacterial infection [ Time Frame: Day 15 post-operative or upon study exit, if earlier ]
    As assessed by the investigator during slit-lamp examination.
Change History Complete list of historical versions of study NCT01515826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
  • Cells in the anterior chamber (study eye) [ Time Frame: Day 15 post-operative ]
    As assessed by the investigator during slit-lamp examination.
  • Ocular pain (study eye) [ Time Frame: Day 15 post-operative ]
    As assessed by the investigator during patient interview.
  • Inflammatory reaction (study eye) [ Time Frame: Day 15 post-operative ]
    As assessed by the investigator during slit-lamp examination.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
  • Cells in the anterior chamber (study eye) [ Time Frame: Day 15 post-operative or upon study exit, if earlier ]
    As assessed by the investigator during slit-lamp examination.
  • Ocular pain (study eye) [ Time Frame: Day 15 post-operative or upon study exit, if earlier ]
    As assessed by the investigator during patient interview.
  • Inflammatory reaction (study eye) [ Time Frame: Day 15 post-operative or upon study exit, if earlier ]
    As assessed by the investigator during slit-lamp examination.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery
Official Title  ICMJE Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery
Brief Summary The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cataracts
Intervention  ICMJE
  • Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
    One ribbon (approximately 1-1.5 cm) administered topically in the conjunctival sac of the study eye three times daily (TID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
    Other Name: FID 119149, VIGADEXA Gel
  • Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
    One drop administered topically in the conjunctival sac of the study eye four times daily (QID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
    Other Name: VIGADEXA Solution
Study Arms  ICMJE
  • Experimental: VIGADEXA Gel
    VIGADEXA ophthalmic gel topically administered TID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.
    Intervention: Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
  • Active Comparator: VIGADEXA Solution
    VIGADEXA ophthalmic solution topically administered QID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.
    Intervention: Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 24, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2012)
184
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older.
  • Diagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery.
  • Able to understand and sign an informed consent form.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Glaucoma or ocular hypertension.
  • Use of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to surgery or planned use during the study. Low-dose acetylsalicylic acid (up to 100 mg/day) is allowed.
  • Use of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol.
  • Secondary implantation or replacement of the intra-ocular lens (IOL) in the study eye.
  • Planned use of contact lenses in the study eye during the study period.
  • Cataract surgery in the contralateral eye within 30 days prior to the Screening Visit, or planned for the 3 weeks after the cataract surgery in the study eye.
  • History of clinically significant trauma to the study eye within the past 12 months.
  • Other protocol-defined exclusion criteria may apply.
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 Not Provided
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT01515826
Other Study ID Numbers  ICMJE C-10-013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date March 2014

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