Trial · NCT01109173
Confirmatory Study Nepafenac 0.3%
NCT01109173, Phase 3, Completed, Alcon Research; results first posted 2012-11-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Confirmatory Study Nepafenac 0.3%. Trials, record NCT01109173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01109173
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Confirmatory Study Nepafenac 0.3%
- NCT number
- NCT01109173
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,120 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Cataract
- Interventions
- Nepafenac Ophthalmic Suspension, 0.3%, Nepafenac Ophthalmic Suspension, 0.1%, Nepafenac Ophthalmic Suspension 0.3% Vehicle, NEVANAC Vehicle
- First posted
- 2010-04-23
- Last updated
- 2012-11-30
- Results first posted
- 2012-11-30
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes2
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 | 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 | 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. |
Source ClinicalTrials.gov
Outcomes2
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 | Day 14 | All randomized patients with at least one postoperative assessment (ITT), last observation carried forward. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Pain-Free at Day 14 | Day 14 | All randomized patients with at least one postoperative assessment (ITT), last observation carried forward. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
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% | 68.4 | percentage of participants | ||
| Percentage of Patients Cured at Day 14 | NEVANAC | 70.0 | percentage of participants | ||
| Percentage of Patients Cured at Day 14 | Nepafenac Vehicle 0.3% | 34.0 | percentage of participants | ||
| Percentage of Patients Cured at Day 14 | NEVANAC Vehicle | 35.6 | percentage of participants | ||
| Percentage of Patients Pain-Free at Day 14 | Nepafenac 0.3% | 91 | percentage of participants | ||
| Percentage of Patients Pain-Free at Day 14 | NEVANAC | 90.9 | percentage of participants | ||
| Percentage of Patients Pain-Free at Day 14 | Nepafenac Vehicle 0.3% | 49.7 | percentage of participants | ||
| Percentage of Patients Pain-Free at Day 14 | NEVANAC Vehicle | 56.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nepafenac 0.3% | 851 | |
| Overall Study | STARTED | NEVANAC | 845 | |
| Overall Study | STARTED | Nepafenac Vehicle 0.3% | 211 | |
| Overall Study | STARTED | NEVANAC Vehicle | 213 | |
| Overall Study | COMPLETED | Nepafenac 0.3% | 763 | |
| Overall Study | COMPLETED | NEVANAC | 759 | |
| Overall Study | COMPLETED | Nepafenac Vehicle 0.3% | 110 | |
| Overall Study | COMPLETED | NEVANAC Vehicle | 120 | |
| Overall Study | NOT COMPLETED | Nepafenac 0.3% | 88 | |
| Overall Study | NOT COMPLETED | NEVANAC | 86 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
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 | Appendicitis | Infections and infestations | Nepafenac 0.3% | 1 | 817 | |
| serious | Appendicitis | Infections and infestations | NEVANAC | 0 | 819 | |
| serious | Appendicitis | Infections and infestations | Nepafenac Vehicle 0.3% | 0 | 200 | |
| serious | Appendicitis | Infections and infestations | NEVANAC Vehicle | 0 | 206 | |
| serious | Brain Oedema | Nervous system disorders | Nepafenac 0.3% | 1 | 817 | |
| serious | Brain Oedema | Nervous system disorders | NEVANAC | 0 | 819 | |
| serious | Brain Oedema | Nervous system disorders | Nepafenac Vehicle 0.3% | 0 | 200 | |
| serious | Brain Oedema | Nervous system disorders | NEVANAC Vehicle | 0 | 206 | |
| serious | Cerebrovascular Accident | Nervous system disorders | Nepafenac 0.3% | 1 | 817 | |
| serious | Cerebrovascular Accident | Nervous system disorders | NEVANAC | 1 | 819 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nepafenac 0.3% | ||
| Total, all-cause mortality | NEVANAC | ||
| Total, all-cause mortality | Nepafenac Vehicle 0.3% | ||
| Total, all-cause mortality | NEVANAC Vehicle | ||
| Total, other adverse events | Nepafenac 0.3% | 0 | 817 |
| Total, other adverse events | NEVANAC | 0 | 819 |
| Total, other adverse events | Nepafenac Vehicle 0.3% | 0 | 200 |
| Total, other adverse events | NEVANAC Vehicle | 0 | 206 |
| Total, serious adverse events | Nepafenac 0.3% | 7 | 817 |
| Total, serious adverse events | NEVANAC | 3 | 819 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01109173
GET https://conductscience.org/api/trials/v1/NCT01109173/events?page=2