Status:
WITHDRAWN
VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery
Lead Sponsor:
Alcon Research
Conditions:
Cataracts
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01515826
Start Date
March 1 2014
End Date
October 1 2014
Last Update
March 26 2014
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