Study of Safety and Performance of a Novel Ocular Lubricant in 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).

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kindred Optics at Maitland Vision Center, Maitland, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FID123300 ocular lubricant

Other

Investigational ocular lubricant

Primary outcomes

Change From Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30

Time frame: Baseline (Day 1); 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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 5, 2024
Registry last updated: Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed