Trial · NCT01743729

A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

NCT01743729, Phase 3, Completed, Shire; results first posted 2017-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye. Trials, record NCT01743729. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01743729

On this page

Trial

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

Title: A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
NCT number: NCT01743729
Status: Completed
Phases: Phase 3
Enrollment: 720 participants, actual
Lead sponsor: Shire
Conditions: Dry Eye Disease
Interventions: Lifitegrast, Placebo
First posted: 2012-12-06
Last updated: 2021-06-23
Results first posted: 2017-02-24

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84	Baseline to Day 84	Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Primary	Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84	Baseline to Day 84	Eye dryness score was assessed on a visual analogue scale (a 7-item \[burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain\], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.

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	Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84	Baseline to Day 84	Intent-to-treat (ITT) set included all randomized participants who received at least 1 dose of study drug.	units on a scale	MEAN
PRIMARY	Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84	Baseline to Day 84	ITT population with last observation carried forward (LOCF).	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84	Lifitegrast	Baseline	2.39	Standard Deviation 0.763	units on a scale
Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84	Placebo	Baseline	2.40	Standard Deviation 0.722	units on a scale
Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84	Lifitegrast	Change from Baseline to Day 84	-0.73	Standard Deviation 0.926	units on a scale
Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84	Placebo	Change from Baseline to Day 84	-0.71	Standard Deviation 0.943	units on a scale
Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84	Lifitegrast	Baseline	69.68	Standard Deviation 16.954	units on a scale
Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84	Placebo	Baseline	69.22	Standard Deviation 16.761	units on a scale
Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84	Lifitegrast	Change from Baseline to Day 84	-35.30	Standard Deviation 28.400	units on a scale
Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84	Placebo	Change from Baseline to Day 84	-22.75	Standard Deviation 28.600	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lifitegrast	358
Overall Study	STARTED	Placebo	360
Overall Study	COMPLETED	Lifitegrast	321
Overall Study	COMPLETED	Placebo	348
Overall Study	NOT COMPLETED	Lifitegrast	37
Overall Study	NOT COMPLETED	Placebo	12

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	Visual acuity reduced	Eye disorders	Lifitegrast	18	359	23
other	Visual acuity reduced	Eye disorders	Placebo	23	359	28
other	Instillation site irritation	General disorders	Lifitegrast	28	359	29
other	Instillation site irritation	General disorders	Placebo	5	359	5
other	Instillation site reaction	General disorders	Lifitegrast	25	359	29
other	Instillation site reaction	General disorders	Placebo	4	359	4
other	Dysgeusia	Nervous system disorders	Lifitegrast	58	359	58
other	Dysgeusia	Nervous system disorders	Placebo	1	359	1
serious	Vertigo	Ear and labyrinth disorders	Lifitegrast	1	359	1
serious	Vertigo	Ear and labyrinth disorders	Placebo	0	359	0

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lifitegrast
Total, all-cause mortality	Placebo
Total, other adverse events	Lifitegrast	102	359
Total, other adverse events	Placebo	30	359
Total, serious adverse events	Lifitegrast	3	359
Total, serious adverse events	Placebo	4	359

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26365210	RESULT

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Lifitegrast vs Placebo: serious adverse events

Source 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/NCT01743729

GET https://conductscience.org/api/trials/v1/NCT01743729/events?page=2

API reference For AI assistants