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Completed

NCT Number: NCT05056155

Systane Complete Multi-symptom Relief

The purpose of this study is to demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED).

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 1455, Kansas City, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systane Complete

Other

Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film

Other names: Systane® Complete Lubricant Eye Drops

Primary outcomes

  1. Change from Baseline at Day 28 in IDEEL-SB Question "Sore"

    Time frame: 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.

  2. Change from Baseline at Day 28 in IDEEL-SB Question "Stinging"

    Time frame: 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.

  3. Change from Baseline at Day 28 in IDEEL-SB Question "Burning"

    Time frame: 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.

  4. Change from Baseline at Day 28 in IDEEL-SB Question "Tired Eyes"

    Time frame: 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.

  5. Change from Baseline at Day 28 in DEQ-5 Question "Watery"

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2021
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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