Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-12-30

Brief Summary

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A prospective, non- interventional, observational, non-comparative, longitudinal cohort study design will be used to address the objectives of this study using data collected through a healthcare.

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Detailed Description

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The study will identify patients with DED who newly initiated treatment with lifitegrast ophthalmic solution on or after the start of the recruitment period, which will last for 1 year since first patient first visit (FPFV) (index period). A minimum follow-up period of 6 months (post-index period) is set for each patient making the last patient last visit (LPLV) 6 months after the closure of recruitment period or after the last patient recruited, whichever comes first.

Conditions

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Dry Eye Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single arm of DED patients

1. Age ≥18 years at index date.
2. Confirmed diagnosis of DED.
3. Newly started on lifitegrast ophthalmic solution within the recruitment period and not receiving lifitegrast ophthalmic solution within 6 months prior to recruitment.
4. Received continuous medical care at the healthcare site defined as at least one clinical visit within 6 months.

lifitegrast

Intervention Type DRUG

patient newly started on medication will be followed for 6 months

Interventions

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lifitegrast

patient newly started on medication will be followed for 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years at index date.
2. Confirmed diagnosis of DED.
3. Newly started on lifitegrast ophthalmic solution within the recruitment period and not receiving lifitegrast ophthalmic solution within 6 months prior to recruitment.
4. Received continuous medical care at the healthcare site defined as at least one clinical visit within 6 months.
5. Clinical decision made to initiate treatment with lifitegrast ophthalmic solution prior to enrollment in the study.
6. Patient agrees to be included after signing an informed consent.

Exclusion Criteria

1. Known hypersensitivity to lifitegrast or its components.
2. Dry eye secondary to scarring or destruction of conjunctival goblet cells.
3. Patients with active or history of ocular herpes and or other ocular infection within the last 30 days.
4. Any contra-indication as per the label.
5. Refusal to give signed informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No