NCT06444516

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 4, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2025

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

May 31, 2024

Results QC Date

January 30, 2026

Last Update Submit

January 30, 2026

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

FID123300

EXPERIMENTAL

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

Interventions

FID123300 ocular lubricantOTHER

Investigational ocular lubricant

FID123300

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Kindred Optics at Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Franklin Park Eye Center, PC

Franklin Park, Illinois, 60131, United States

Location

Kannarr Eye Care, LLC

Pittsburg, Kansas, 66762, United States

Location

SUNY College of Optometry Clinical Vision Research Center

New York, New York, 10036, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

Wyomissing Optometric Center

Wyomissing, Pennsylvania, 19610, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

Clarke Eyecare Center

Wichita Falls, Texas, 76308, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Sr. Principal I, Clinical Project Management
Organization
Alcon Research, LLC
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Sr. Clinical Trial Lead, Vision Care

    Alcon Research, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 5, 2024

Study Start

September 4, 2024

Primary Completion

February 7, 2025

Study Completion

February 7, 2025

Last Updated

February 18, 2026

Results First Posted

February 18, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(9)