Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery
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| ClinicalTrials.gov Identifier: NCT00333255 |
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Recruitment Status
:
Completed
First Posted
: June 2, 2006
Last Update Posted
: July 8, 2009
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Sponsor:
Alcon Research
Information provided by:
Alcon Research
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- No Results Posted
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Brief Summary:
The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cataract | Drug: Nepafenac Ophthalmic Suspension, 0.1% | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 267 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single |
| Primary Purpose: | Treatment |
| Official Title: | Preoperative and Postoperative Nevanac 0.1% Compared to Acular LS for the Treatment of Ocular Inflammation Associated With Cataract Surgery |
| Study Start Date : | September 2005 |
| Actual Primary Completion Date : | March 2006 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Nepafenac
U.S. FDA Resources
Primary Outcome Measures
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- Percentage of patients who are a clinical success at Day 14 postoperative visit (where a "clinical success" is defined as aqueous cells < grade 1 and aqueous flare = grade 0 at the current visit and all subsequent visits).
Secondary Outcome Measures
:
- Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation
Information from the National Library of Medicine
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| Ages Eligible for Study: | 10 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- planned cataract extraction with posterior chamber intraocular lens implantation
Exclusion Criteria:
- Under 10
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333255
Locations
| United States, Texas | |
| Lehmann Eye Center | |
| Nacogdoches, Texas, United States, 76134 | |
Sponsors and Collaborators
Alcon Research
Investigators
| Study Director: | Andrew Maxwell | Study Director |
| ClinicalTrials.gov Identifier: | NCT00333255 History of Changes |
| Other Study ID Numbers: |
C-04-41 |
| First Posted: | June 2, 2006 Key Record Dates |
| Last Update Posted: | July 8, 2009 |
| Last Verified: | July 2009 |
Additional relevant MeSH terms:
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Inflammation Cataract Pathologic Processes Lens Diseases Eye Diseases Nepafenac Ketorolac Ketorolac Tromethamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |