Trial · NCT00905450

Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery

NCT00905450, Phase 2, Completed, Bausch & Lomb Incorporated; results first posted 2020-09-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery. Trials, record NCT00905450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00905450

On this page

Trial

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

Title: Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
NCT number: NCT00905450
Status: Completed
Phases: Phase 2
Enrollment: 415 participants, actual
Lead sponsor: Bausch & Lomb Incorporated
Conditions: Cataract, Inflammation
Interventions: BOL-303242-X, Vehicle for BOL-303242-X
First posted: 2009-05-20
Last updated: 2020-09-22
Results first posted: 2020-09-03

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 Participants With Complete Resolution of Anterior Chamber (AC) Cells.	8 days	Anterior chamber (AC) cells will be assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. Pigment cells and red blood cells are to be ignored. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.
Secondary	Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.	8 days	A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. Complete resolution of AC flare was defined as Grade 0.

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 Participants With Complete Resolution of Anterior Chamber (AC) Cells.	8 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.	8 days		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Value	Units
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	1% Twice a Day	35	Participants
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	2% Once a Day	19	Participants
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	2% Twice a Day	15	Participants
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	2% Four Times a Day	47	Participants
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	3% Once a Day	42	Participants
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	3% Twice a Day	45	Participants
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	3% Four Times a Day	42	Participants
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	Vehicle	30	Participants
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.	1% Twice a Day	15	Participants
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.	2% Once a Day	6	Participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow24

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

Period	Milestone	Group	Participants
Overall Study	STARTED	1% Twice a Day	60
Overall Study	STARTED	2% Once a Day	28
Overall Study	STARTED	2% Twice a Day	28
Overall Study	STARTED	2% Four Times a Day	60
Overall Study	STARTED	3% Once a Day	59
Overall Study	STARTED	3% Twice a Day	60
Overall Study	STARTED	3% Four Times a Day	60
Overall Study	STARTED	Vehicle	60
Overall Study	COMPLETED	1% Twice a Day	59
Overall Study	COMPLETED	2% Once a Day	27

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events144

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	Headache	Nervous system disorders	1% Twice a Day	2	60
other	Headache	Nervous system disorders	2% Once a Day	0	28
other	Headache	Nervous system disorders	2% Twice a Day	0	28
other	Headache	Nervous system disorders	2% Four Times a Day	4	60
other	Headache	Nervous system disorders	3% Once a Day	1	59
other	Headache	Nervous system disorders	3% Twice a Day	1	60
other	Headache	Nervous system disorders	3% Four Times a Day	0	60
other	Headache	Nervous system disorders	Vehicle	0	60
other	Eye pain	Eye disorders	1% Twice a Day	7	60
other	Eye pain	Eye disorders	2% Once a Day	4	28

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1% Twice a Day
Total, all-cause mortality	2% Once a Day
Total, all-cause mortality	2% Twice a Day
Total, all-cause mortality	2% Four Times a Day
Total, all-cause mortality	3% Once a Day
Total, all-cause mortality	3% Twice a Day
Total, all-cause mortality	3% Four Times a Day
Total, all-cause mortality	Vehicle
Total, other adverse events	1% Twice a Day	43	60
Total, other adverse events	2% Once a Day	20	28

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

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.

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/NCT00905450

GET https://conductscience.org/api/trials/v1/NCT00905450/flow?page=2

API reference For AI assistants