A Single-Arm Study to Evaluate and Demonstrate Safety and Performance of a Novel Ocular Lubricant in Adult Subjects With Dry Eye Disease
Overview
- Phase
- Not Applicable
- Intervention
- FID123300 ocular lubricant
- Conditions
- Dry Eye Disease
- Sponsor
- Alcon Research
- Enrollment
- 188
- Locations
- 9
- Primary Endpoint
- Change From Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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
- •Other protocol-defined inclusion criteria may apply.
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.
Arms & Interventions
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
Intervention: FID123300 ocular lubricant
Outcomes
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).