Dry Eye Disease
Conditions
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.
Interventions
Investigational ocular lubricant
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
Countries
United States
Contacts
STUDY_DIRECTORSr. Clinical Trial Lead, Vision Care
Alcon Research, LLC
Participant flow
Recruitment details
Subjects were recruited from 9 investigative sites located in the United States.
Pre-assignment details
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).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 14.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 11 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 16 Participants |
| Race/Ethnicity, Customized Multi-Racial | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 139 Participants |
| Race/Ethnicity, Customized Not Reported | 5 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Race/Ethnicity, Customized White | 138 Participants |
| Region of Enrollment United States | 161 participants |
| Sex/Gender, Customized Female | 121 Participants |
| Sex/Gender, Customized Male | 39 Participants |
| Sex/Gender, Customized Unknown | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 161 |
| other Total, other adverse events | 0 / 161 |
| serious Total, serious adverse events | 0 / 161 |
Outcome results
None listed