Trial · NCT01636206

Safety Study of Lifitegrast to Treat Dry Eye

NCT01636206, Phase 3, Completed, Shire; results first posted 2016-10-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study of Lifitegrast to Treat Dry Eye. Trials, record NCT01636206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01636206

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Trial

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

Title: Safety Study of Lifitegrast to Treat Dry Eye
NCT number: NCT01636206
Status: Completed
Phases: Phase 3
Enrollment: 332 participants, actual
Lead sponsor: Shire
Conditions: Dry Eye Disease
Interventions: Lifitegrast, Placebo
First posted: 2012-07-10
Last updated: 2021-06-11
Results first posted: 2016-10-03

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year	Day 0 to Day 360

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	Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year	Day 0 to Day 360	Safety population included all randomized participants who received at least 1 dose of investigational product.	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	Category	Value	Units
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year	Placebo	Ocular TEAE	38	participants
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year	Lifitegrast	Ocular TEAE	118	participants
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year	Placebo	Non-ocular TEAE	40	participants
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year	Lifitegrast	Non-ocular TEAE	104	participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	111
Overall Study	STARTED	Lifitegrast	221
Overall Study	COMPLETED	Placebo	92
Overall Study	COMPLETED	Lifitegrast	170
Overall Study	NOT COMPLETED	Placebo	19
Overall Study	NOT COMPLETED	Lifitegrast	51

Source ClinicalTrials.gov

Adverse events44

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	Dry eye	Eye disorders	Placebo	6	111	6
other	Dry eye	Eye disorders	Lifitegrast	4	220	4
other	Visual acuity reduced	Eye disorders	Placebo	7	111	8
other	Visual acuity reduced	Eye disorders	Lifitegrast	25	220	28
other	Instillation site irritation	General disorders	Placebo	5	111	5
other	Instillation site irritation	General disorders	Lifitegrast	33	220	33
other	Instillation site reaction	General disorders	Placebo	2	111	2
other	Instillation site reaction	General disorders	Lifitegrast	29	220	30
other	Dysgeusia	Nervous system disorders	Placebo	2	111	2
other	Dysgeusia	Nervous system disorders	Lifitegrast	36	220	36

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Lifitegrast
Total, other adverse events	Placebo	22	111
Total, other adverse events	Lifitegrast	92	220
Total, serious adverse events	Placebo	6	111
Total, serious adverse events	Lifitegrast	9	220

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27055211	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/NCT01636206

GET https://conductscience.org/api/trials/v1/NCT01636206/events?page=2

API reference For AI assistants