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The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic Suspension, 0.3% 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 drop was administered between 30-120 minutes prior to surgery. |
|
| Nepafenac 0.1% | Active Comparator | Nepafenac Ophthalmic Suspension, 0.1%, 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 drop was administered between 30-120 minutes prior to surgery. |
|
| Nepafenac Vehicle 0.3% | Placebo Comparator | Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery. |
|
| 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 drop was administered between 30-120 minutes prior to surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3% | 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 aqueous cells and aqueous flare. | Day 14 postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1% | 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 aqueous cells and aqueous flare. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Percentage of Patients Cured by Visit | 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 aqueous cells and aqueous flare. To be included in the cumulative summary at a visit, a patient must have been declared cured at the visit and remained cured at all subsequent visits. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 1342 enrolled patients, 60 withdrew before the start of dosing. Baseline characteristics are presented on all randomized patients with at least one postoperative assessment (intent-to-treat): 1257
Patients were randomized from 37 investigational sites in the US.
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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 drop was administered between 30-120 minutes prior to surgery. |
| FG001 | Nepafenac 0.1% | Nepafenac Ophthalmic Suspension, 0.1%, 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 drop was administered between 30-120 minutes prior to surgery. |
| FG002 | Nepafenac Vehicle 0.3% | Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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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 drop 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, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3% | 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 aqueous cells and aqueous flare. | All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward. | Posted | Number | Percentage of patients | Day 14 postoperative |
|
Adverse events were collected for the duration of the study.
The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/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 drop was administered between 30-120 minutes prior to surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angle closure glaucoma | Eye disorders | MedDRA 13.0 | Not related |
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Study excluded patients who were under the age of 18, had uncontrolled glaucoma, were at risk of developing macular edema (diabetic retinopathy), and women 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 |
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery. |
|
|
| Nepafenac Vehicle 0.3% | Other | Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery. |
|
| Day 7 postoperative |
| Day 1, Day 3, Day 7, Day 14 |
| Cumulative Percentage of Patients Pain Free by Visit | Ocular pain was assessed by the patient on a 6-unit scale from 0 (none; absence of positive sensation), to 5 (severe; intense ocular, periocular or radiating pain requiring prescription analgesic). Pain free was defined as an ocular pain assessment score of 0. To be included in the cumulative summary at a visit, a patient must have been declared pain free at the visit and remained pain free at all subsequent visits. | Day 1, Day 3, Day 7, Day 14 |
| Noncompliance |
|
| Treatment Failure |
|
| Protocol Violation |
|
| Patient Did Not Use Study Medication |
|
| Other |
|
| Nepafenac 0.1% |
Nepafenac Ophthalmic Suspension, 0.1%, 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 drop was administered between 30-120 minutes prior to surgery. |
| BG002 | Nepafenac Vehicle 0.3% | Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Nepafenac Vehicle 0.3% | Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery. |
|
|
| Secondary | Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1% | 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 aqueous cells and aqueous flare. | All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward. | Posted | Number | Percentage of patients | Day 7 postoperative |
|
|
|
| Post-Hoc | Cumulative Percent Clinical Success by Visit | 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). Clinical success occurred when the cell grade was ≤ 1 (0-5 cells) and flare grade was = 0. To be included in the cumulative summary at a visit, a patient must have been declared a clinical success at the visit and remained a clinical success at all subsequent visits. | All randomized patients with at least one post-operative assessment (intent-to-treat). | Posted | Number | Percentage of patients | Day 1, Day 3, Day 7, Day 14 |
|
|
|
| Other Pre-specified | Cumulative Percentage of Patients Cured by Visit | 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 aqueous cells and aqueous flare. To be included in the cumulative summary at a visit, a patient must have been declared cured at the visit and remained cured at all subsequent visits. | All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward. | Posted | Number | Percentage of patients | Day 1, Day 3, Day 7, Day 14 |
|
|
|
| Other Pre-specified | Cumulative Percentage of Patients Pain Free by Visit | Ocular pain was assessed by the patient on a 6-unit scale from 0 (none; absence of positive sensation), to 5 (severe; intense ocular, periocular or radiating pain requiring prescription analgesic). Pain free was defined as an ocular pain assessment score of 0. To be included in the cumulative summary at a visit, a patient must have been declared pain free at the visit and remained pain free at all subsequent visits. | All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward. | Posted | Number | Percentage of patients | Day 1, Day 3, Day 7, Day 14 |
|
|
|
| 5 |
| 522 |
| 0 |
| 522 |
| EG001 | Nepafenac 0.1% | Nepafenac Ophthalmic Suspension, 0.1%, 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 drop was administered between 30-120 minutes prior to surgery. | 4 | 506 | 0 | 506 |
| EG002 | Nepafenac Vehicle 0.3% | Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery. | 0 | 254 | 0 | 254 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Not related |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 13.0 | Not related |
|
| Endophthalmitis | Infections and infestations | MedDRA 13.0 | Not related |
|
| Hypopyon | Infections and infestations | MedDRA 13.0 | Not related |
|
| Lens dislocation | Eye disorders | MedDRA 13.0 | Not related |
|
| Retinal detachment | Eye disorders | MedDRA 13.0 | Not related |
|
| Gastritis viral | Infections and infestations | MedDRA 13.0 | Not related |
|
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 13.0 | Not related |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Not related |
|
| Visual acuity reduced | Eye disorders | MedDRA 13.0 | Not related |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Day 7 |
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| Day 14 |
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| Title | Measurements |
|---|---|
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| Day 7 |
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| Day 14 |
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| Title | Measurements |
|---|---|
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| Day 7 |
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| Day 14 |
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