Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID123300 ocular lubricant | Other | Investigational ocular lubricant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kindred Optics at Maitland Vision Center | Maitland | Florida | 32751 | United States | ||
| Vision Health Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 188 subjects enrolled in the study (consented), 27 were exited as screen failures. This reporting group includes all subjects exposed to the study product (161).
Subjects were recruited from 9 investigative sites located in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 27, 2024 | Jan 24, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Orlando |
| Florida |
| 32803 |
| United States |
| Franklin Park Eye Center, PC | Franklin Park | Illinois | 60131 | United States |
| Kannarr Eye Care, LLC | Pittsburg | Kansas | 66762 | United States |
| SUNY College of Optometry Clinical Vision Research Center | New York | New York | 10036 | United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| Wyomissing Optometric Center | Wyomissing | Pennsylvania | 19610 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| Clarke Eyecare Center | Wichita Falls | Texas | 76308 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Safety Analysis Set with data at both visits | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1); Day 30 |
|
|
|
|
Adverse events were collected from time of consent until study exit, approximately 37 days.
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. The Safety Analysis Set included all subjects/eyes exposed to at least one dose of the investigational product evaluated in this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 161 | 0 | 161 | 0 | 161 |
Not provided
Not provided
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Principal I, Clinical Project Management | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2025 | Jan 24, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| Unknown |
|
| Not Reported |
|
| Unknown |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Multi-Racial |
|