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

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

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Other: FID123300 ocular lubricant

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Kindred Optics at Maitland Vision Center
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Illinois
    • Franklin Park, Illinois, United States, 60131
      • Franklin Park Eye Center, PC
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care, LLC
  • New York
    • New York, New York, United States, 10036
      • SUNY College of Optometry Clinical Vision Research Center
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Wyomissing Optometric Center
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC
  • Texas
    • Wichita Falls, Texas, United States, 76308
      • Clarke EyeCare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FID123300; One drop of FID123300 ocular lubricant in each eye on Day 1 in the morning, followed by at least one drop in each eye 4 times a day on Days 2-30	Other: FID123300 ocular lubricant; Investigational ocular lubricant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30	The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0=I did not have this symptom/Not applicable; 1=I had this symptom and it bothered me not at all; 2=I had this symptom and it bothered me slightly; 3=I had this symptom and it bothered me moderately; and 4=I had this symptom and it bothered me very much. The overall Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25 and ranged from 0 (minimum) to 100 (maximum). Baseline was defined as the last non-missing value prior to the start date of the study treatment. Change from baseline was calculated as Day 30 minus baseline. A negative change value represents an improvement (less symptom bother).	Baseline (Day 1); Day 30

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Actual): February 7, 2025
• Study Completion (Actual): February 7, 2025

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: DEP918-C001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No