Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:

A Single-Arm Study to Evaluate and Demonstrate Safety and Performance of a Novel Ocular Lubricant in Adult Subjects With Dry Eye Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444516
• Other study ID #: DEP918-C001
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).

Description:

The study will consist of a Screening visit, a Baseline visit on Day 1, a remote Compliance Check on Day 14, and an Exit visit on Day 30. The expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 185
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Willing and able to understand and sign an approved informed consent form.

• Exhibit symptoms of dry eye at the Screening visit.

• Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit.

• Willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at Visit 2/Day 1.

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Pregnant, breastfeeding, or planning to become pregnant during the study.

• Ocular abnormalities that could adversely affect the safety or efficacy outcome.

• Uncontrolled active systemic diseases.

• Use of systemic medications known to cause dry eye.

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Other:
• FID123300 ocular lubricant
Investigational ocular lubricant

Locations

Country	Name	City	State
United States	Franklin Park Eye Center, PC	Franklin Park	Illinois
United States	ProCare Vision Center	Granville	Ohio
United States	Lee Shettle Eye	Largo	Florida
United States	Kindred Optics at Maitland Vision Center	Maitland	Florida
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	SUNY College of Optometry Clinical Vision Research Center	New York	New York
United States	Vision Health Institute	Orlando	Florida
United States	Kannarr Eye Care, LLC	Pittsburg	Kansas
United States	Clarke Eyecare Center	Wichita Falls	Texas
United States	Wyomissing Optometric Center	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30	The IDEEL-SB module consists of 20 questions that assess general dry eye symptoms a subject may experience. For each question, the subject will be instructed to select a single response that best represents their answer. The Symptom Bother score is calculated as the mean value of the non-missing item scores 1-20 multiplied by 25. A paired (one-sample) t-test will be used on the change from baseline value at Day 30 for hypothesis testing.	Baseline (Day 1); Day 30