Trial · NCT00521456

A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery

NCT00521456, Phase 3, Completed, Allergan; results first posted 2009-10-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery. Trials, record NCT00521456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00521456

On this page

Trial

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

Title: A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
NCT number: NCT00521456
Status: Completed
Phases: Phase 3
Enrollment: 263 participants, actual
Lead sponsor: Allergan
Conditions: Cataract Extraction
Interventions: ketorolac eye drops
First posted: 2007-08-27
Last updated: 2009-10-01
Results first posted: 2009-10-01

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Resolution of Post Operative Inflammation	Day 14	Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = \>50 cells)
Secondary	Ocular Pain	Day 1	Measured on a scale of 0-4 (0 = none, 4 = intolerable)
Secondary	Mean Pupil Area	Day 0	Pupil area post-irrigation and aspiration

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Resolution of Post Operative Inflammation	Day 14	Modified Intent-to-Treat Population	% of participants with a score of 0	NUMBER
SECONDARY	Ocular Pain	Day 1	Modified Intent-to-Treat Population	% of participants with a score of 0	NUMBER
SECONDARY	Mean Pupil Area	Day 0	Modified Intent-to-Treat Population	millimeters squared (mm²)	MEAN
POST_HOC	Visual Acuity	Change from baseline at Day 14	Modified Intent-to-Treat Population	Percentage of patients with ≥ 3 lines	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Resolution of Post Operative Inflammation	Ketorolac Solution	58.0		% of participants with a score of 0
Resolution of Post Operative Inflammation	Vehicle Solution	27.3		% of participants with a score of 0
Ocular Pain	Ketorolac Solution	70.0		% of participants with a score of 0
Ocular Pain	Vehicle Solution	38.5		% of participants with a score of 0
Mean Pupil Area	Ketorolac Solution	37.9	Standard Deviation 12.0	millimeters squared (mm²)
Mean Pupil Area	Vehicle Solution	36.5	Standard Deviation 13.5	millimeters squared (mm²)
Visual Acuity	Ketorolac Solution	56.9		Percentage of patients with ≥ 3 lines
Visual Acuity	Vehicle Solution	36.3		Percentage of patients with ≥ 3 lines

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ketorolac Solution	176
Overall Study	STARTED	Vehicle Solution	87
Overall Study	COMPLETED	Ketorolac Solution	163
Overall Study	COMPLETED	Vehicle Solution	59
Overall Study	NOT COMPLETED	Ketorolac Solution	13
Overall Study	NOT COMPLETED	Vehicle Solution	28

Source ClinicalTrials.gov

Adverse events18

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
other	Conjunctival Hyperaemia	Eye disorders	Ketorolac Solution	12	173
other	Conjunctival Hyperaemia	Eye disorders	Vehicle Solution	11	82
other	Anterior chamber cell	Eye disorders	Ketorolac Solution	12	173
other	Anterior chamber cell	Eye disorders	Vehicle Solution	6	82
other	Anterior chamber flare	Eye disorders	Ketorolac Solution	11	173
other	Anterior chamber flare	Eye disorders	Vehicle Solution	6	82
other	Corneal edema	Eye disorders	Ketorolac Solution	9	173
other	Corneal edema	Eye disorders	Vehicle Solution	8	82
other	Eye pain	Eye disorders	Ketorolac Solution	7	173
other	Eye pain	Eye disorders	Vehicle Solution	10	82

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Ketorolac Solution
Total, all-cause mortality	Vehicle Solution
Total, other adverse events	Ketorolac Solution	68
Total, other adverse events	Vehicle Solution	57
Total, serious adverse events	Ketorolac Solution	1
Total, serious adverse events	Vehicle Solution	0

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21145532	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 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.

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/NCT00521456

GET https://conductscience.org/api/trials/v1/NCT00521456/registered

API reference For AI assistants