Cataract
Conditions
Brief summary
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.
Interventions
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%, one drop in affected eye three times daily, for 16 days
OTHERNepafenac 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.
OTHERNEVANAC Vehicle
Nepafenac vehicle, one drop in affected eye three times daily, for 16 days
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens; * 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; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit; * 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; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Cured at Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Pain-Free at Day 14 | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were randomized from 65 sites in 5 countries: US (49), Hungary (6), Italy (4), Sweden (4), and Switzerland (2).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 807 |
| 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. | 813 |
| 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. | 197 |
| 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. | 205 |
| Total | 2,022 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 15 | 17 | 9 | 6 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Noncompliance | 0 | 1 | 0 | 0 |
| Overall Study | Not Specifiied | 5 | 4 | 9 | 14 |
| Overall Study | Patient Decision Unrelated to Advrs Evnt | 5 | 0 | 2 | 0 |
| Overall Study | Patient Did Not Use Study Medication | 34 | 26 | 11 | 7 |
| Overall Study | Protocol Violation | 4 | 5 | 1 | 2 |
| Overall Study | Treatment Failure | 25 | 32 | 69 | 64 |
Baseline characteristics
| Characteristic | Nepafenac 0.3% | NEVANAC | Nepafenac Vehicle 0.3% | NEVANAC Vehicle | Total |
|---|---|---|---|---|---|
| Age Continuous | 68.7 years STANDARD_DEVIATION 9.08 | 68.8 years STANDARD_DEVIATION 9.31 | 69.8 years STANDARD_DEVIATION 9.31 | 68.9 years STANDARD_DEVIATION 9.37 | 68.9 years STANDARD_DEVIATION 9.22 |
| Sex: Female, Male Female | 465 Participants | 458 Participants | 118 Participants | 115 Participants | 1156 Participants |
| Sex: Female, Male Male | 342 Participants | 355 Participants | 79 Participants | 90 Participants | 866 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 817 | 0 / 819 | 0 / 200 | 0 / 206 |
| serious Total, serious adverse events | 7 / 817 | 3 / 819 | 0 / 200 | 0 / 206 |
Outcome results
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.
Time frame: Day 14
Population: All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nepafenac 0.3% | Percentage of Patients Cured at Day 14 | 68.4 percentage of participants |
| NEVANAC | Percentage of Patients Cured at Day 14 | 70.0 percentage of participants |
| Nepafenac Vehicle 0.3% | Percentage of Patients Cured at Day 14 | 34.0 percentage of participants |
| NEVANAC Vehicle | Percentage of Patients Cured at Day 14 | 35.6 percentage of participants |
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.
Time frame: Day 14
Population: All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nepafenac 0.3% | Percentage of Patients Pain-Free at Day 14 | 91 percentage of participants |
| NEVANAC | Percentage of Patients Pain-Free at Day 14 | 90.9 percentage of participants |
| Nepafenac Vehicle 0.3% | Percentage of Patients Pain-Free at Day 14 | 49.7 percentage of participants |
| NEVANAC Vehicle | Percentage of Patients Pain-Free at Day 14 | 56.1 percentage of participants |