Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease
- Conditions
- Dry Eye Disease
- Interventions
- Other: FID123300 ocular lubricant
- Registration Number
- NCT06444516
- Lead Sponsor
- Alcon Research
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FID123300 FID123300 ocular lubricant 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30 Baseline (Day 1); 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Kindred Optics at Maitland Vision Center
🇺🇸Maitland, Florida, United States
Vision Health Institute
🇺🇸Orlando, Florida, United States
Franklin Park Eye Center, PC
🇺🇸Franklin Park, Illinois, United States
Kannarr Eye Care, LLC
🇺🇸Pittsburg, Kansas, United States
SUNY College of Optometry Clinical Vision Research Center
🇺🇸New York, New York, United States
ProCare Vision Center
🇺🇸Granville, Ohio, United States
Wyomissing Optometric Center
🇺🇸Wyomissing, Pennsylvania, United States
Optometry Group, PLLC
🇺🇸Memphis, Tennessee, United States
Clarke Eyecare Center
🇺🇸Wichita Falls, Texas, United States