Systane Complete Multi-symptom Relief

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Other: Systane Complete

• Registration Number: NCT05056155
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-24
• Study Start: 2021-11-09
• Status Verified: 2022-03
• Primary Completion: 2022-03-25
• Study Completion: 2022-03-25
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Systane Complete	Systane Complete	First dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days

Primary Outcome Measures

Name	Time	Method
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 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 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.

Trial Locations

Locations (4)

Alcon Investigator 8046; 🇺🇸 Granville, Ohio, United States

Alcon Investigator 1455; 🇺🇸 Kansas City, Missouri, United States

Alcon Investigator 6313; 🇺🇸 Powell, Ohio, United States

Alcon Investigator 8175; 🇺🇸 Austin, Texas, United States