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OpenTrials
Completed

NCT Number: NCT03492541

Study of Efficacy and Tolerability of SYSTANE Complete in Patients With Dry Eye Disease

The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Investigative Site, Valladolid, Castille and León, Spain

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About this study

Patients will attend 4 scheduled visits: Screening Visit (Day -7 to Day 0), Visit 1/Baseline Visit (Day 1), Visit 2 (Day 14) and Visit 3 (Day 28).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have TFBUT of ≤ 5 seconds in at least one eye at Screening visit.
  • Must have best corrected visual acuity (BCVA) of ≥ 20/80 (or ≥ 55 letters score or ≥ 0.6 early treatment diabetic retinopathy study (ETDRS) log of the minimum angle of resolution (LogMAR) value) in both eyes at the Screening visit.
  • Must be willing to discontinue use of all artificial tear supplements and use only the study product as directed for the entire study duration.

Exclusion criteria

  • History of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes.
  • Use of any topical ocular medication preserved with benzalkonium chloride or other products known to be toxic to the tear film lipid layer within 1 month prior to the Screening visit.

Other protocol-specified inclusion and exclusion criteria may apply.

Treatment and study plan

Propylene glycol-based eye drops

Other

Nano-emulsion ocular lubricant

Other names: SYSTANE® Complete

Primary outcomes

  1. Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14

    Time frame: Baseline, Day 14

    TFBUT will be assessed using fluorescein, an ocular staining dye

Secondary outcomes

  1. Change from baseline in dry eye symptom score at Day 1

    Time frame: Baseline, Day 1

    As reported by the patient using a Likert scale post drop instillation

  2. Soothing sensation score

    Time frame: Day 1

    As reported by the patient using a Likert scale post drop instillation

  3. Tolerability assessment score

    Time frame: Day 1

    As reported by the patient using an assessment questionnaire post drop instillation

  4. Change from baseline in ocular discomfort at Day 14

    Time frame: Baseline, Day 14

    As reported by the patient using a Visual Analogue Scale (VAS)

  5. Change from baseline in corneal staining score at Day 28

    Time frame: Baseline, Day 28

    Assessment of ocular staining using staining dye under a slit lamp

  6. Change from baseline in response to the revised IDEEL questionnaire at Day 28

    Time frame: Baseline, Day 28

    As reported by the patient using a subjective questionnaire

  7. Change from baseline in EQ-5D-5L score(s) at Day 28

    Time frame: Baseline, Day 28

    As reported by the patient using a validated questionnaire

  8. Change from baseline in TFBUT at Day 28

    Time frame: Baseline, Day 28

    TFBUT will be assessed using fluorescein, an ocular staining dye

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Evaluation of the Clinical Efficacy and Tolerability of SYSTANE Complete in Adult Patients With Dry Eye Disease Following Topical Ocular Use for 4 Weeks: A Multicenter Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2018
Registry last updated
Jun 12, 2019

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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