Systane Complete Multi-symptom Relief

Dry Eye Disease Clinical Trial

Official title:

Systane Complete Multi-symptom Relief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056155
• Other study ID #: DEC262-P002
• Status: Completed
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: March 25, 2022

Study information

• Verified date: March 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 exclusion criteria may apply.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Other:
• Systane Complete
Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film

Locations

Country	Name	City	State
United States	Alcon Investigator 8175	Austin	Texas
United States	Alcon Investigator 8046	Granville	Ohio
United States	Alcon Investigator 1455	Kansas City	Missouri
United States	Alcon Investigator 6313	Powell	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline at Day 28 in IDEEL-SB Question "Sore"	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.	Baseline (Day 0), Day 28
Primary	Change from Baseline at Day 28 in IDEEL-SB Question "Stinging"	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.	Baseline (Day 0), Day 28
Primary	Change from Baseline at Day 28 in IDEEL-SB Question "Burning"	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.	Baseline (Day 0), Day 28
Primary	Change from Baseline at Day 28 in IDEEL-SB Question "Tired Eyes"	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.	Baseline (Day 0), Day 28
Primary	Change from Baseline at Day 28 in DEQ-5 Question "Watery"	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.	Baseline (Day 0), Day 28