Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
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ClinicalTrials.gov Identifier: NCT00405730 |
Recruitment Status :
Completed
First Posted : November 30, 2006
Last Update Posted : November 18, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataracts | Drug: Nepafenac 1mg/ml eye drops, suspension Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution Other: Nepafenac vehicle eye drops | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 227 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | July 2006 |
Actual Study Completion Date : | July 2006 |
Arm | Intervention/treatment |
---|---|
Experimental: Nepafenac
One drop in the study eye 3 times daily for 23 days
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Drug: Nepafenac 1mg/ml eye drops, suspension
One drop in the study eye 3 times daily for 23 days |
Active Comparator: Ketorolac Trometamol
One drop in the study eye 3 times daily for 23 days
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Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution
One drop in the study eye 3 times daily for 23 days |
Placebo Comparator: Nepafenac Vehicle
One drop in the study eye 3 times daily for 23 days
|
Other: Nepafenac vehicle eye drops
One drop in the study eye 3 times daily for 23 days |
- Percentage of Patients with Day 14 Cure [ Time Frame: Day 14 ]Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Under 18.
- Other protocol-defined exclusion criteria may apply.

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): NCT00405730
France | |
Bordeaux | |
Bordeaux, France, 33000 |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00405730 |
Other Study ID Numbers: |
C-04-65 2005-002647-35 |
First Posted: | November 30, 2006 Key Record Dates |
Last Update Posted: | November 18, 2016 |
Last Verified: | April 2012 |
Cataracts |
Cataract Lens Diseases Eye Diseases Ketorolac Ketorolac Tromethamine Nepafenac Ophthalmic Solutions Pharmaceutical Solutions 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 |