Trial · NCT00703781
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
NCT00703781, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2011-12-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery. Trials, record NCT00703781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00703781
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
- NCT number
- NCT00703781
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 126 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Cataract
- Interventions
- bromfenac ophthalmic solution, placebo
- First posted
- 2008-06-24
- Last updated
- 2015-03-24
- Results first posted
- 2011-12-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Day 15 | Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense) |
| Secondary | Number of Participants That Are Pain Free | Day 1 | Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop |
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 | Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Day 15 | Last Observation Carried Forward Analysis (LOCF). Intent to treat population (ITT) | Participants | NUMBER |
| SECONDARY | Number of Participants That Are Pain Free | Day 1 | LOCF Analysis, ITT Population | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Bromfenac | 28 | Participants | ||
| Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Placebo | 20 | Participants | ||
| Number of Participants That Are Pain Free | Bromfenac | 51 | Participants | ||
| Number of Participants That Are Pain Free | Placebo | 46 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bromfenac | 63 | |
| Overall Study | STARTED | Placebo | 63 | |
| Overall Study | COMPLETED | Bromfenac | 61 | |
| Overall Study | COMPLETED | Placebo | 61 | |
| Overall Study | NOT COMPLETED | Bromfenac | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events22
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 |
|---|---|---|---|---|---|---|
| other | Corneal Edema | Eye disorders | Bromfenac | 4 | 61 | 4 |
| other | Corneal Edema | Eye disorders | Placebo | 2 | 61 | 2 |
| other | Lacrimation Increased | Eye disorders | Bromfenac | 3 | 61 | 4 |
| other | Lacrimation Increased | Eye disorders | Placebo | 6 | 61 | 7 |
| other | Eye Pain | Eye disorders | Bromfenac | 5 | 61 | 6 |
| other | Eye Pain | Eye disorders | Placebo | 7 | 61 | 9 |
| other | Eye Inflammation | Eye disorders | Bromfenac | 8 | 61 | 13 |
| other | Eye Inflammation | Eye disorders | Placebo | 14 | 61 | 15 |
| other | Eye Pruritus | Eye disorders | Bromfenac | 6 | 61 | 6 |
| other | Eye Pruritus | Eye disorders | Placebo | 2 | 61 | 2 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bromfenac | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Bromfenac | 46 | 61 |
| Total, other adverse events | Placebo | 61 | 61 |
| Total, serious adverse events | Bromfenac | 2 | 61 |
| Total, serious adverse events | Placebo | 0 | 61 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bromfenac vs Placebo: Number of Participants That Are Pain Free | Trial comparisons |
| Bromfenac vs Placebo: Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Trial comparisons |
| Bromfenac vs Placebo: serious adverse events | Trial comparisons |
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/NCT00703781
GET https://conductscience.org/api/trials/v1/NCT00703781/events?page=2