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

NCT05857748 | Withdrawn

• 1 other identifier: CLIF606A1AE01
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dry Eye Disease

Keywords

Dry eye disease; DED; NIS; United Arab Emirates

Outcome Measures

Primary Outcomes (1)

• Percentage of patients attaining 30% improvement of eye dryness from Baseline

  Percentage of patients attaining 30% improvement of eye dryness from Baseline at Month 3 (using the Eye Dryness Score -(EDS)). The EDS is rated using a visual analog scale (VAS) measured on a scale of 0 (no discomfort) to 100 (maximal discomfort).

  Baseline, month 3

Secondary Outcomes (29)

• Percentage of patients describing eye dryness using EDS score

  Day 0, Day 1, month 3 and month 6

• Percentage of patients describing ocular burning/stinging, ocular pain, foreign body sensation, itching, eye discomfort, photophobia

  Day 0, Day 1, month 3 and month 6

• Percentage of patients describing visual symptoms such as reduced vision, blurred vision, and fluctuation relative to DED

  Day 0, Day 1, month 3 and month 6

• Dry Eye Questionnaire-5 (DEQ5) 5-item

  Day 0, Day 1, month 3 and month 6

• Percentage of DED patients with matrix metalloproteinase-9 (MMP-9) levels

  Day 0, Day 1, month 3 and month 6

Study Arms (1)

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.

Drug: lifitegrast

Interventions

lifitegrast DRUG

patient newly started on medication will be followed for 6 months

Single arm of DED patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will include newly started DED patients on lifitegrast ophthalmic solution: DED diagnosed patients who did not receive lifitegrast ophthalmic solution during the 6 months prior to the index date; that started lifitegrast ophthalmic solution during the active recruitment period. The patient will be the unit of analysis. This is critical in the inclusion/exclusion and study analysis. .

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 15, 2023
• Study Start: July 31, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share