Trial · NCT01276223

Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

NCT01276223, Phase 2, Completed, Alcon Research; results first posted 2013-03-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients. Trials, record NCT01276223. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01276223

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Trial

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

Title: Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients
NCT number: NCT01276223
Status: Completed
Phases: Phase 2
Enrollment: 722 participants, actual
Lead sponsor: Alcon Research
Conditions: Dry Eye Disease
Interventions: Difluprednate 0.05% ophthalmic emulsion, Difluprednate vehicle
First posted: 2011-01-13
Last updated: 2013-03-11
Results first posted: 2013-03-11

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Baseline, up to 4 weeks	A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Baseline, up to 4 weeks	All subjects randomized to treatment and receiving at least 1 administration of study medication (ITT). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Category	Value	Spread	Units
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Durezol	Baseline (Week 0)	78.3	Standard Deviation 14.4	units on a scale
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Vehicle	Baseline (Week 0)	76.8	Standard Deviation 13.8	units on a scale
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Durezol	Change from Baseline to Week 1	-1.1	Standard Deviation 8.8	units on a scale
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Vehicle	Change from Baseline to Week 1	-1.7	Standard Deviation 12.4	units on a scale
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Durezol	Change from Baseline to Week 2	-4.4	Standard Deviation 10.9	units on a scale
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Vehicle	Change from Baseline to Week 2	-4.2	Standard Deviation 14.7	units on a scale
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Durezol	Change from Baseline to Week 3	-4.5	Standard Deviation 13.4	units on a scale
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Vehicle	Change from Baseline to Week 3	-4.8	Standard Deviation 16.2	units on a scale
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Durezol	Change from Baseline to Week 4	-6.2	Standard Deviation 15.1	units on a scale
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Vehicle	Change from Baseline to Week 4	-4.7	Standard Deviation 16.1	units on a scale

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Run-In Only	78
Overall Study	STARTED	Durezol	107
Overall Study	STARTED	Vehicle	104
Overall Study	COMPLETED	Run-In Only	67
Overall Study	COMPLETED	Durezol	103
Overall Study	COMPLETED	Vehicle	101
Overall Study	NOT COMPLETED	Run-In Only	11
Overall Study	NOT COMPLETED	Durezol	4
Overall Study	NOT COMPLETED	Vehicle	3

Source ClinicalTrials.gov

Adverse events15

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	Eye pain	Eye disorders	Run-In	29	289
other	Eye pain	Eye disorders	Durezol	1	107
other	Eye pain	Eye disorders	Vehicle	2	104
other	Eye irritation	Eye disorders	Run-In	22	289
other	Eye irritation	Eye disorders	Durezol	1	107
other	Eye irritation	Eye disorders	Vehicle	2	104
other	Intraocular pressure increased	Investigations	Run-In	1	289
other	Intraocular pressure increased	Investigations	Durezol	10	107
other	Intraocular pressure increased	Investigations	Vehicle	0	104
serious	Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Run-In	0	289

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Run-In
Total, all-cause mortality	Durezol
Total, all-cause mortality	Vehicle
Total, other adverse events	Run-In	47	289
Total, other adverse events	Durezol	12	107
Total, other adverse events	Vehicle	3	104
Total, serious adverse events	Run-In	0	289
Total, serious adverse events	Durezol	1	107
Total, serious adverse events	Vehicle	1	104

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 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/NCT01276223

GET https://conductscience.org/api/trials/v1/NCT01276223/registered

API reference For AI assistants