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Ocular Lubricant

Ocular Lubricant for Dry Eye Syndrome

N/A
Recruiting
Research Sponsored by Alcon Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Exhibit symptoms of dry 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
Must not have
Ocular abnormalities that could adversely affect the safety or efficacy outcome
Uncontrolled active systemic diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1); day 30
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new eye drop for people with mild to moderate dry eye disease to see if it works well and is safe to use.

Who is the study for?
This trial is for individuals with mild to moderate dry eye disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.
What is being tested?
The trial is testing a new eye drop called FID123300 designed to lubricate the eyes. The goal is to see if it's effective and safe in providing relief for those suffering from symptoms of dry eye syndrome.
What are the potential side effects?
While specific side effects are not listed, ocular lubricants can sometimes cause temporary blurred vision, discomfort or irritation in the eyes, redness, or an allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have symptoms of dry eye.
Select...
I am willing to stop using my current eye drops and only use the study's eye drops starting from Visit 2/Day 1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have eye problems that could affect treatment results.
Select...
I do not have any uncontrolled diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1); day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1); day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FID123300Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Alcon ResearchLead Sponsor
731 Previous Clinical Trials
128,643 Total Patients Enrolled
Sr. Clinical Trial Lead, Vision CareStudy DirectorAlcon Research, LLC
3 Previous Clinical Trials
345 Total Patients Enrolled
~92 spots leftby Feb 2025
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