VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

This study has been withdrawn prior to enrollment.
(Management decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01515826
First received: January 19, 2012
Last updated: March 24, 2014
Last verified: March 2014

January 19, 2012
March 24, 2014
March 2014
October 2014   (final data collection date for primary outcome measure)
  • Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during slit-lamp examination.
  • Percentage of patients with no clinically evidenced bacterial infection [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during slit-lamp examination.
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during slit-lamp examination.
Complete list of historical versions of study NCT01515826 on ClinicalTrials.gov Archive Site
  • Cells in the anterior chamber (study eye) [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during slit-lamp examination.
  • Ocular pain (study eye) [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during patient interview.
  • Inflammatory reaction (study eye) [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during slit-lamp examination.
  • Cells in the anterior chamber (study eye) [ Time Frame: Day 15 post-operative or upon study exit, if earlier ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during patient interview.
  • Inflammatory reaction (study eye) [ Time Frame: Day 15 post-operative or upon study exit, if earlier ] [ Designated as safety issue: Yes ]
    As assessed by the investigator during slit-lamp examination.
Not Provided
Not Provided
 
VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery
Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Cataracts
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2014
October 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01515826
C-10-013
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
March 2014

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