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Trial record 45 of 8394 for:    Ophthalmopathy

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03492541
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Other: Propylene glycol-based eye drops Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 18, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : May 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: SYSTANE Complete
Propylene glycol-based eye drops, 1 drop in each eye twice a day (BID) (morning and evening) for 28 days. Patients can administer additional doses in between the scheduled daily doses as needed
Other: Propylene glycol-based eye drops
Nano-emulsion ocular lubricant
Other Name: SYSTANE® Complete




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492541


Locations
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United States, Missouri
Investigative Site
Kansas City, Missouri, United States, 64133
Investigative Site
Kansas City, Missouri, United States, 64155
United States, Virginia
Investigative Site
Norfolk, Virginia, United States, 23502
Spain
Investigative Site
Valladolid, Castilla Y Leon, Spain, 47011
United Kingdom
Investigative Site
London, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon Pharmaceuticals Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03492541     History of Changes
Other Study ID Numbers: CDMGD0012401
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alcon Research:
mixed dry eye
aqueous-deficient dry eye
lipid-deficient dry eye
evaporative dry eye
tear film
eye drops
artificial tears
lipid layer
eye symptoms
meibomian gland dysfunction
MGD
SYSTANE
SYSTANE Complete
nanoemulsion

Additional relevant MeSH terms:
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Eye Diseases
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions