Trial · NCT01318499
Nepafenac 0.3% Two Study
NCT01318499, Phase 2, Completed, Alcon Research; results first posted 2012-12-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nepafenac 0.3% Two Study. Trials, record NCT01318499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01318499
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nepafenac 0.3% Two Study
- NCT number
- NCT01318499
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,342 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Cataract
- Interventions
- Nepafenac Ophthalmic Suspension, 0.3%, Nepafenac Ophthalmic Suspension, 0.1%, Nepafenac Vehicle 0.3%
- First posted
- 2011-03-18
- Last updated
- 2012-12-17
- Results first posted
- 2012-12-17
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3% | Day 14 postoperative | 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. |
| Secondary | Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1% | Day 7 postoperative | 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. |
| Other | Cumulative Percentage of Patients Cured by Visit | Day 1, Day 3, Day 7, 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 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. |
| Other | Cumulative Percentage of Patients Pain Free by Visit | Day 1, Day 3, Day 7, Day 14 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3% | Day 14 postoperative | All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1% | Day 7 postoperative | All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward. | Percentage of patients | NUMBER |
| POST_HOC | Cumulative Percent Clinical Success by Visit | Day 1, Day 3, Day 7, Day 14 | All randomized patients with at least one post-operative assessment (intent-to-treat). | Percentage of patients | NUMBER |
| OTHER_PRE_SPECIFIED | Cumulative Percentage of Patients Cured by Visit | Day 1, Day 3, Day 7, Day 14 | All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward. | Percentage of patients | NUMBER |
| OTHER_PRE_SPECIFIED | Cumulative Percentage of Patients Pain Free by Visit | Day 1, Day 3, Day 7, Day 14 | All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward. | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3% | Nepafenac 0.3% | 64.6 | Percentage of patients | ||
| Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3% | Nepafenac Vehicle 0.3% | 25.0 | Percentage of patients | ||
| Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1% | Nepafenac 0.3% | 31.3 | Percentage of patients | ||
| Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1% | Nepafenac 0.1% | 30.8 | Percentage of patients | ||
| Cumulative Percent Clinical Success by Visit | Nepafenac 0.3% | Day 1 | 18.9 | Percentage of patients | |
| Cumulative Percent Clinical Success by Visit | Nepafenac 0.1% | Day 1 | 15.0 | Percentage of patients | |
| Cumulative Percent Clinical Success by Visit | Nepafenac Vehicle 0.3% | Day 1 | 12.3 | Percentage of patients | |
| Cumulative Percent Clinical Success by Visit | Nepafenac 0.3% | Day 3 | 43.9 | Percentage of patients | |
| Cumulative Percent Clinical Success by Visit | Nepafenac 0.1% | Day 3 | 35.9 | Percentage of patients | |
| Cumulative Percent Clinical Success by Visit | Nepafenac Vehicle 0.3% | Day 3 | 18.7 | Percentage of patients |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nepafenac 0.3% | 540 | |
| Overall Study | STARTED | Nepafenac 0.1% | 534 | |
| Overall Study | STARTED | Nepafenac Vehicle 0.3% | 268 | |
| Overall Study | COMPLETED | Nepafenac 0.3% | 475 | |
| Overall Study | COMPLETED | Nepafenac 0.1% | 458 | |
| Overall Study | COMPLETED | Nepafenac Vehicle 0.3% | 121 | |
| Overall Study | NOT COMPLETED | Nepafenac 0.3% | 65 | |
| Overall Study | NOT COMPLETED | Nepafenac 0.1% | 76 | |
| Overall Study | NOT COMPLETED | Nepafenac Vehicle 0.3% | 147 |
Source ClinicalTrials.gov
Adverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Angle closure glaucoma | Eye disorders | Nepafenac 0.3% | 1 | 522 | |
| serious | Angle closure glaucoma | Eye disorders | Nepafenac 0.1% | 0 | 506 | |
| serious | Angle closure glaucoma | Eye disorders | Nepafenac Vehicle 0.3% | 0 | 254 | |
| serious | Cardiac failure congestive | Cardiac disorders | Nepafenac 0.3% | 1 | 522 | |
| serious | Cardiac failure congestive | Cardiac disorders | Nepafenac 0.1% | 0 | 506 | |
| serious | Cardiac failure congestive | Cardiac disorders | Nepafenac Vehicle 0.3% | 0 | 254 | |
| serious | Corneal abrasion | Injury, poisoning and procedural complications | Nepafenac 0.3% | 1 | 522 | |
| serious | Corneal abrasion | Injury, poisoning and procedural complications | Nepafenac 0.1% | 0 | 506 | |
| serious | Corneal abrasion | Injury, poisoning and procedural complications | Nepafenac Vehicle 0.3% | 0 | 254 | |
| serious | Endophthalmitis | Infections and infestations | Nepafenac 0.3% | 1 | 522 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nepafenac 0.3% | ||
| Total, all-cause mortality | Nepafenac 0.1% | ||
| Total, all-cause mortality | Nepafenac Vehicle 0.3% | ||
| Total, other adverse events | Nepafenac 0.3% | 0 | 522 |
| Total, other adverse events | Nepafenac 0.1% | 0 | 506 |
| Total, other adverse events | Nepafenac Vehicle 0.3% | 0 | 254 |
| Total, serious adverse events | Nepafenac 0.3% | 5 | 522 |
| Total, serious adverse events | Nepafenac 0.1% | 4 | 506 |
| Total, serious adverse events | Nepafenac Vehicle 0.3% | 0 | 254 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01318499
GET https://conductscience.org/api/trials/v1/NCT01318499/results?page=2