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The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nepafenac 0.3% | Experimental | 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. |
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| NEVANAC | Active Comparator | 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 Vehicle 0.3% | Placebo Comparator | 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. |
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| NEVANAC Vehicle | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepafenac Ophthalmic Suspension, 0.3% | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Cured at Day 14 | Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Pain-Free at Day 14 | Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain. | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Sager, MS | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 2120 enrolled participants, 78 withdrew before the start of dosing. Baseline characteristics are presented on all randomized patients with at least 1 postoperative assessment (ITT): 2022.
Patients were randomized from 65 sites in 5 countries: US (49), Hungary (6), Italy (4), Sweden (4), and Switzerland (2).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Cured at Day 14 | Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare. | All randomized patients with at least one postoperative assessment (ITT), last observation carried forward. | Posted | Number | percentage of participants | Day 14 |
|
Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment | Not related |
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This study excluded patients who were under the age of 18, had uncontrolled glaucoma, were at risk of developing macular edema (eg, diabetic retinopathy), or of childbearing potential. Therefore, results may not be generalizable to these populations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Sager, Clinical Manager Group Leader | Alcon Research | 1-817-551-8603 | dana.sager@alconlabs.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
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| Nepafenac Ophthalmic Suspension, 0.1% | Drug | Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days |
|
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| Nepafenac Ophthalmic Suspension 0.3% Vehicle | Other | 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. |
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| NEVANAC Vehicle | Other | Nepafenac vehicle, one drop in affected eye three times daily, for 16 days |
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| Lost to Follow-up |
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| Patient Decision Unrelated to Advrs Evnt |
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| Noncompliance |
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| Treatment Failure |
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| Protocol Violation |
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| Patient Did Not Use Study Medication |
|
| Not Specifiied |
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| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| Secondary | Percentage of Patients Pain-Free at Day 14 | Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain. | All randomized patients with at least one postoperative assessment (ITT), last observation carried forward. | Posted | Number | percentage of participants | Day 14 |
|
|
|
| 7 |
| 817 |
| 0 |
| 817 |
| EG001 | 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. | 3 | 819 | 0 | 819 |
| EG002 | 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. | 0 | 200 | 0 | 200 |
| EG003 | 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. | 0 | 206 | 0 | 206 |
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| Brain Oedema | Nervous system disorders | MedDRA (13.0) | Systematic Assessment | Not related |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA (13.0) | Systematic Assessment | Not related |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment | Not related |
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| Injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment | Not related |
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| Lung Carcinoma Cell Type Unspecified Stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment | Not related |
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| Myocardial Infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment | Not related |
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| Atrial Fibrillation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment | Not related |
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| Sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment | Not related |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.