Dry Eye Disease
Conditions
Keywords
Eye drops
Brief summary
The purpose of this study is to demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED).
Detailed description
Subjects will be expected to attend a screening/baseline visit and one additional visit at Day 28 (± 2 days), with a telephone call visit conducted at Day 14 (± 2 days). Individual duration of subject participation will be approximately 28 days.
Interventions
OTHERSystane Complete
Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film
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: * Able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form. * Willing and able to attend all study visits as required per protocol. * Have dry eye symptoms as specified in the protocol. * Willing to discontinue use of all habitual artificial tear supplements for the entire study duration. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Ocular conditions as specified in the protocol. * Contact lens use within one week prior to screening visit. * Use of medications as specified in the protocol. * Pregnant or breast feeding. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline at Day 28 in IDEEL-SB Question Sore | Baseline (Day 0), Day 28 | The Impact of Dry Eye on Everyday Life - Symptoms Bother (IDEEL-SB) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Sore Eyes? using a 0-4 Likert-type scale, where 0 = I did not have this symptom/Not applicable and 4 = Very Much. A negative change value will represent perceived improvement. |
| Change from Baseline at Day 28 in IDEEL-SB Question Stinging | Baseline (Day 0), Day 28 | Subjects will respond to the question, OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Stinging Eyes? using a 0-4 Likert-type scale, where 0 = I did not have this symptom/Not applicable and 4 = Very Much. A negative change value will represent perceived improvement. |
| Change from Baseline at Day 28 in IDEEL-SB Question Burning | Baseline (Day 0), Day 28 | Subjects will respond to the question, OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Burning Eyes? using a 0-4 Likert-type scale, where 0 = I did not have this symptom/Not applicable and 4 = Very Much. A negative change value will represent perceived improvement. |
| Change from Baseline at Day 28 in IDEEL-SB Question Tired Eyes | Baseline (Day 0), Day 28 | Subjects will respond to the question, OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Tired Eyes? using a 0-4 Likert-type scale, where 0 = I did not have this symptom/Not applicable and 4 = Very Much. A negative change value will represent perceived improvement. |
| Change from Baseline at Day 28 in DEQ-5 Question Watery | Baseline (Day 0), Day 28 | The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, During a typical day in the past month, how often did your eyes look or feel excessively watery? using a 0-4 Likert-type scale, where 0 = Never and 4 = Constantly. A negative change value will represent perceived improvement. |
Countries
United States
Outcome results
None listed