Systane Complete Multi-symptom Relief

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT05056155
Collaborator
(none)
119
4
1
4.5
29.8
6.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Systane Complete
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
119 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Systane Complete Multi-symptom Relief
Actual Study Start Date :
Nov 9, 2021
Actual Primary Completion Date :
Mar 25, 2022
Actual Study Completion Date :
Mar 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: Systane Complete
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
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Investigator 1455 Kansas City Missouri United States 64111
    2 Alcon Investigator 8046 Granville Ohio United States 43023
    3 Alcon Investigator 6313 Powell Ohio United States 43065
    4 Alcon Investigator 8175 Austin Texas United States 78731

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Trial Lead, Ocular Health, Alcon Research, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT05056155
    Other Study ID Numbers:
    • DEC262-P002
    First Posted:
    Sep 24, 2021
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alcon Research
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022