Cataracts
Conditions
Keywords
Cataract surgery, Topical therapy, Prevention of inflammation, Inflammation of infection
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.
Interventions
DRUGMoxifloxacin 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.
DRUGMoxifloxacin 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.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber | Day 15 post-operative | As assessed by the investigator during slit-lamp examination. |
| Percentage of patients with no clinically evidenced bacterial infection | Day 15 post-operative | As assessed by the investigator during slit-lamp examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cells in the anterior chamber (study eye) | Day 15 post-operative | As assessed by the investigator during slit-lamp examination. |
| Ocular pain (study eye) | Day 15 post-operative | As assessed by the investigator during patient interview. |
| Inflammatory reaction (study eye) | Day 15 post-operative | As assessed by the investigator during slit-lamp examination. |
Outcome results
None listed