Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
2120 participants
INTERVENTIONAL
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nepafenac 0.3%
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
NEVANAC
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
Nepafenac Ophthalmic Suspension, 0.1%
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days
Nepafenac Vehicle 0.3%
Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
Nepafenac Ophthalmic Suspension 0.3% Vehicle
Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
NEVANAC Vehicle
Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
NEVANAC Vehicle
Nepafenac vehicle, one drop in affected eye three times daily, for 16 days
Interventions
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Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
Nepafenac Ophthalmic Suspension, 0.1%
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days
Nepafenac Ophthalmic Suspension 0.3% Vehicle
Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
NEVANAC Vehicle
Nepafenac vehicle, one drop in affected eye three times daily, for 16 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who, in the opinion of the Investigator, would have improvement in best-corrected visual acuity after surgery;
* Able to understand and sign an informed consent;
Exclusion Criteria
* Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit;
* History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye;
* Diabetic retinopathy in the operative eye;
* Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article;
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Dana Sager, MS
Role: STUDY_DIRECTOR
Alcon Research
Locations
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Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States
Countries
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Other Identifiers
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C-09-055
Identifier Type: -
Identifier Source: org_study_id