---
title: Effect of Lifitegrast 5% on Tear Film Markers
nct_id: NCT03952481
overall_status: WITHDRAWN
phase: PHASE4
sponsor: Weill Medical College of Cornell University
study_type: INTERVENTIONAL
primary_condition: Dry Eye
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03952481.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03952481"
ct_last_update_post_date: 2021-02-16
last_seen_at: "2026-05-12T06:29:59.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Lifitegrast 5% on Tear Film Markers

**Official Title:** Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study

**NCT ID:** [NCT03952481](https://clinicaltrials.gov/study/NCT03952481)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** COVID restrictions
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Weill Medical College of Cornell University
- **Collaborators:** Novartis
- **Conditions:** Dry Eye, Dry Eye Syndromes, Dry Eyes Chronic
- **Start Date:** 2021-03-01
- **Completion Date:** 2021-12-31
- **CT.gov Last Update:** 2021-02-16

## Brief Summary

The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Signs or symptoms of Dry Eye Disease
* 18 years or older
* Abnormal MMP9 (positive as read by 2 blinded investigators with both in agreement) and/or Abnormal tear osmolarity (greater than or equal to 308 or an inter-eye difference \>=8 mOsm/mL)

Exclusion Criteria:

* Active eye infection. Patients with blepharitis may be enrolled.
* Any eye drop that was instilled within 2 hours of the Baseline eye exam
* Current contact lens wearer. Subjects who have not worn contact lenses 30 days prior to baseline and have no intention to wear CLs during the study duration may enroll.
* History of ocular herpes simplex
* Active episcleritis, scleritis, iritis or uveitis
* Active keratitis secondary to any etiology other than dry eyes
* History of refractive surgery (LASIK or PRK) or penetrating corneal transplant (PK)
* Uses eye drops (ex. glaucoma or allergy drops) for indications other than dry eyes
* Active allergic conjunctivitis
* Current use of punctal plugs or anticipation of use during the study
* Use of topical ophthalmic steroids within 14 days of the Baseline Visit or anticipated use during the study
* Use of lifitegrast 5% or Restasis within 30 Days of the Baseline Visit.
* Allergy to lifitegrast 5%
```

## Arms

- **Lifitegrast 5% Ophthalmic Solution** (EXPERIMENTAL) — Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.

## Interventions

- **Lifitegrast 5% Ophthalmic Solution** (DRUG) — Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.

## Primary Outcomes

- **The change in proportion of subjects demonstrating improved tear film osmolarity** _(time frame: Baseline, Weeks 1, 2, 3 and 4)_ — Improved tear film osmolarity will be defined as an osmolarity reading of less than or equal to 308 mOsm/L or an inter-eye difference osmolarity reading of less than or equal to 8 mOsm/L.

## Secondary Outcomes

- **The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9).** _(time frame: Week 4)_
- **The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT).** _(time frame: Week 4)_
- **The proportion of subjects demonstrating normal corneal fluorescein staining.** _(time frame: Week 4)_
- **The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire.** _(time frame: Week 4)_

## Locations (1)

- Weill Cornell Ophthalmology, New York, New York, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.weill cornell ophthalmology|new york|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03952481.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03952481*  
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