Trial · NCT00853970

Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

NCT00853970, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2011-01-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery. Trials, record NCT00853970. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00853970

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
NCT number: NCT00853970
Status: Completed
Phases: Phase 3
Enrollment: 299 participants, actual
Lead sponsor: Bausch & Lomb Incorporated
Conditions: Pain, Inflammation
Interventions: Bromfenac Ophthalmic Solution, Placebo Comparator
First posted: 2009-03-02
Last updated: 2013-01-25
Results first posted: 2011-01-26

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Summed Ocular Inflammation Score (SOIS) of Zero	Day 15 (Primary Endpoint)	Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)
Secondary	Pain Free	Day 1	Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.

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	Summed Ocular Inflammation Score (SOIS) of Zero	Day 15 (Primary Endpoint)	Last observation carried forward (LOCF) Analysis; Intent to treat (ITT) Population	participants	NUMBER
SECONDARY	Pain Free	Day 1	Last observation carried forward (LOCF) Analysis, Intent to treat (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	Value	Units
Summed Ocular Inflammation Score (SOIS) of Zero	Bromfenac Ophthalmic Solution 0.09%	70	participants
Summed Ocular Inflammation Score (SOIS) of Zero	Placebo	36	participants
Pain Free	Bromfenac Ophthalmic Solution 0.09%	135	participants
Pain Free	Placebo	105	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Bromfenac Ophthalmic Solution 0.09%	152
Overall Study	STARTED	Placebo	147
Overall Study	COMPLETED	Bromfenac Ophthalmic Solution 0.09%	146
Overall Study	COMPLETED	Placebo	144
Overall Study	NOT COMPLETED	Bromfenac Ophthalmic Solution 0.09%	6
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events20

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	Conjunctival hyperemia	Eye disorders	Bromfenac Ophthalmic Solution 0.09%	7	147	7
other	Conjunctival hyperemia	Eye disorders	Placebo	9	144	10
other	Lacrimation increased	Eye disorders	Bromfenac Ophthalmic Solution 0.09%	5	147	5
other	Lacrimation increased	Eye disorders	Placebo	11	144	11
other	Eye Pain	Eye disorders	Bromfenac Ophthalmic Solution 0.09%	13	147	15
other	Eye Pain	Eye disorders	Placebo	34	144	37
other	Eye Inflammation	Eye disorders	Bromfenac Ophthalmic Solution 0.09%	15	147	15
other	Eye Inflammation	Eye disorders	Placebo	21	144	22
other	Foreign body sensation	Eye disorders	Bromfenac Ophthalmic Solution 0.09%	18	147	21
other	Foreign body sensation	Eye disorders	Placebo	20	144	20

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bromfenac Ophthalmic Solution 0.09%
Total, all-cause mortality	Placebo
Total, other adverse events	Bromfenac Ophthalmic Solution 0.09%	69	147
Total, other adverse events	Placebo	86	144
Total, serious adverse events	Bromfenac Ophthalmic Solution 0.09%	0	147
Total, serious adverse events	Placebo	3	144

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21751945	DERIVED

Source PubMed

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 Ophthalmic Solution 0.09% vs Placebo: Summed Ocular Inflammation Score (SOIS) of Zero	Trial comparisons
Bromfenac Ophthalmic Solution 0.09% vs Placebo: Pain Free	Trial comparisons
Bromfenac Ophthalmic Solution 0.09% 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00853970

GET https://conductscience.org/api/trials/v1/NCT00853970/registered

API reference For AI assistants