Trial · NCT02284516

A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)

NCT02284516, Phase 3, Completed, Shire; results first posted 2017-03-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3). Trials, record NCT02284516. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02284516

On this page

Trial

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

Title: A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
NCT number: NCT02284516
Status: Completed
Phases: Phase 3
Enrollment: 711 participants, actual
Lead sponsor: Shire
Conditions: Dry Eye Disease
Interventions: Lifitegrast, Placebo
First posted: 2014-11-06
Last updated: 2021-06-11
Results first posted: 2017-03-15

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 Patient-Reported Eye Dryness Score to Day 84	Baseline to Day 84	Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Secondary	Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42	Baseline to Day 14 and Day 42	Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).

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 Patient-Reported Eye Dryness Score to Day 84	Baseline to Day 84	Intent to treat (ITT) population included all randomized participants who took at least 1 dose of investigational product with last observation carried forward (LOCF). Here, n = number of participants analyzed for the specific categories of each arm, respectively.	units on a scale	MEAN
SECONDARY	Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42	Baseline to Day 14 and Day 42	ITT population with LOCF. Here, n = number of participants analyzed for the specific categories of each arm, respectively.	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
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84	Placebo	Baseline (n=356, 355)	69.0	Standard Deviation 17.08	units on a scale
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84	Lifitegrast	Baseline (n=356, 355)	68.3	Standard Deviation 16.88	units on a scale
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84	Placebo	Change from Baseline to Day 84 (n=353, 353)	-30.7	Standard Deviation 28.01	units on a scale
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84	Lifitegrast	Change from Baseline to Day 84 (n=353, 353)	-37.9	Standard Deviation 28.85	units on a scale
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42	Placebo	Baseline (n=356, 355)	69.0	Standard Deviation 17.08	units on a scale
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42	Lifitegrast	Baseline (n=356, 355)	68.3	Standard Deviation 16.88	units on a scale
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42	Placebo	Change from Baseline to Day 14 (n=353, 352)	-15.0	Standard Deviation 22.40	units on a scale
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42	Lifitegrast	Change from Baseline to Day 14 (n=353, 352)	-22.9	Standard Deviation 25.44	units on a scale
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42	Placebo	Change from Baseline to Day 42 (n=353, 353)	-23.9	Standard Deviation 25.99	units on a scale
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42	Lifitegrast	Change from Baseline to Day 42 (n=353, 353)	-33.2	Standard Deviation 27.42	units on a scale

Source ClinicalTrials.gov

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	356
Overall Study	STARTED	Lifitegrast	355
Overall Study	Safety Population	Placebo	354
Overall Study	Safety Population	Lifitegrast	357
Overall Study	COMPLETED	Placebo	318
Overall Study	COMPLETED	Lifitegrast	319
Overall Study	NOT COMPLETED	Placebo	38
Overall Study	NOT COMPLETED	Lifitegrast	36

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	Instillation site irritation	General disorders	Placebo	11	354	12
other	Instillation site irritation	General disorders	Lifitegrast	65	357	68
other	Instillation site reaction	General disorders	Placebo	19	354	21
other	Instillation site reaction	General disorders	Lifitegrast	45	357	51
other	Dysgeusia	Nervous system disorders	Placebo	1	354	1
other	Dysgeusia	Nervous system disorders	Lifitegrast	46	357	46
serious	Pneumonia	Infections and infestations	Placebo	0	354	0
serious	Pneumonia	Infections and infestations	Lifitegrast	1	357	1
serious	Periprosthetic fracture	Injury, poisoning and procedural complications	Placebo	1	354	1
serious	Periprosthetic fracture	Injury, poisoning and procedural complications	Lifitegrast	0	357	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	Placebo
Total, all-cause mortality	Lifitegrast
Total, other adverse events	Placebo	30	354
Total, other adverse events	Lifitegrast	107	357
Total, serious adverse events	Placebo	4	354
Total, serious adverse events	Lifitegrast	4	357

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28079022	DERIVED	PubMed
34617974	DERIVED	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/NCT02284516

GET https://conductscience.org/api/trials/v1/NCT02284516/events?page=2

API reference For AI assistants