NCT00926185

A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)

Completed Phase 2 Results posted Last updated 9 August 2021

What this trial tests

Phase 2 trial testing Lifitegrast in Dry Eye in 230 participants. Completed in 18 February 2010.

Timeline

3 August 2009

Primary endpoint
18 February 2010

18 February 2010

Quick facts

Lead sponsor	Shire
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	230
Start date	3 August 2009
Primary completion	18 February 2010
Estimated completion	18 February 2010
Sites	5 locations across United States

Drugs / interventions tested

• Lifitegrast (LIFITEGRAST) — full drug profile →
• Placebo

Conditions studied

• Dry Eye — all drugs for Dry Eye →

Sponsor

Shire — full company profile →

Who can join

18 and older, any sex, with Dry Eye. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84 Primary · Day 84

Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. 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=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were

Group	Value	95% CI
Lifitegrast 0.1%	2.03	± 0.868
Lifitegrast 1.0%	1.92	± 0.768
Lifitegrast 5.0%	1.83	± 0.680
Placebo	2.05	± 0.715

Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84 Secondary · Baseline (Day 0) and Day 84

Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. 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=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were

Pre-CAE: Baseline

Group	Value	95% CI
Lifitegrast 0.1%	1.78	± 0.473
Lifitegrast 1.0%	1.82	± 0.508
Lifitegrast 5.0%	1.77	± 0.515
Placebo	1.65	± 0.513

Pre-CAE: CFB to Day 84

Group	Value	95% CI
Lifitegrast 0.1%	0.25	± 0.841
Lifitegrast 1.0%	0.10	± 0.735
Lifitegrast 5.0%	0.05	± 0.773
Placebo	0.40	± 0.802

Post-CAE: Baseline

Group	Value	95% CI
Lifitegrast 0.1%	3.18	± 0.417
Lifitegrast 1.0%	3.28	± 0.610
Lifitegrast 5.0%	3.16	± 0.523
Placebo	3.04	± 0.602

Post-CAE: Day 84

Group	Value	95% CI
Lifitegrast 0.1%	2.86	± 0.962
Lifitegrast 1.0%	2.88	± 0.860
Lifitegrast 5.0%	2.90	± 0.918
Placebo	2.62	± 0.855

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study drug until the end of follow-up visit, up to Day 86. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lifitegrast 0.1%

Serious: 2/57 (4%)

Deaths: —

Lifitegrast 1.0%

Serious: 1/57 (2%)

Deaths: —

Lifitegrast 5.0%

Serious: 0/58 (0%)

Deaths: —

Placebo

Serious: 1/58 (2%)

Deaths: —

Serious adverse events (4 terms)

Reaction	System	Lifitegrast 0.1%	Lifitegrast 1.0%	Lifitegrast 5.0%	Placebo
Cardiac arrest	Cardiac disorders	—	—	—	—
Hip fracture	Injury, poisoning and procedural complications	—	—	—	—
Oxygen saturation decreased	Investigations	—	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Lifitegrast 0.1%	Lifitegrast 1.0%	Lifitegrast 5.0%	Placebo
Instillation site irritation	General disorders	—	—	—	—
Instillation site pain	General disorders	—	—	—	—
Instillation site reaction	General disorders	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—
Visual acuity reduced	Eye disorders	—	—	—	—
Conjunctival haemorrhage	Eye disorders	—	—	—	—

Most-reported serious reactions: Cardiac arrest, Hip fracture, Oxygen saturation decreased, Asthma.

Data from ClinicalTrials.gov NCT00926185 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease.
   Nichols KK, Donnenfeld ED, Karpecki PM, Hovanesian JA, et al · · 2019 · cited 27× · PMID 30112930 · DOI 10.1177/1120672118791936
2. Corneal Fluorescein Staining in FDA-Reviewed Dry Eye Registrational Clinical Trials: Evidence of Limited Endpoint Responsiveness.
   Dabre Z, Mun C, Sheth T, Kim C, et al · · 2026 · PMID 41493896 · DOI 10.1159/000550166