Back to resultsVIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery
Primary Purpose
Cataracts
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts focused on measuring Cataract surgery, Topical therapy, Prevention of inflammation, Inflammation of infection
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VIGADEXA Gel
VIGADEXA Solution
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber
As assessed by the investigator during slit-lamp examination.
Percentage of patients with no clinically evidenced bacterial infection
As assessed by the investigator during slit-lamp examination.
Secondary Outcome Measures
Cells in the anterior chamber (study eye)
As assessed by the investigator during slit-lamp examination.
Ocular pain (study eye)
As assessed by the investigator during patient interview.
Inflammatory reaction (study eye)
As assessed by the investigator during slit-lamp examination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01515826
Brief Title
VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery
Official Title
Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Management decision
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Cataract surgery, Topical therapy, Prevention of inflammation, Inflammation of infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIGADEXA Gel
Arm Type
Experimental
Arm Description
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.
Arm Title
VIGADEXA Solution
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
Other Intervention Name(s)
FID 119149, VIGADEXA Gel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
Other Intervention Name(s)
VIGADEXA Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber
Description
As assessed by the investigator during slit-lamp examination.
Time Frame
Day 15 post-operative
Title
Percentage of patients with no clinically evidenced bacterial infection
Description
As assessed by the investigator during slit-lamp examination.
Time Frame
Day 15 post-operative
Secondary Outcome Measure Information:
Title
Cells in the anterior chamber (study eye)
Description
As assessed by the investigator during slit-lamp examination.
Time Frame
Day 15 post-operative
Title
Ocular pain (study eye)
Description
As assessed by the investigator during patient interview.
Time Frame
Day 15 post-operative
Title
Inflammatory reaction (study eye)
Description
As assessed by the investigator during slit-lamp examination.
Time Frame
Day 15 post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery
We'll reach out to this number within 24 hrs