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Senofilcon A Lenses in Moderate to Severe Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT04096898
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Johnson & Johnson Vision Care, Inc.
Information provided by (Responsible Party):
Timothy T. McMahon, OD, University of Illinois at Chicago

Brief Summary:
A clinical trial using Senofilcon A daily lenses in the treatment of moderate to severe dry eye. This a comparison between signs and symptoms prior to and during treatment.

Condition or disease Intervention/treatment Phase
Moderate to Severe Dry Eye Disease Device: Senofilcon A contact lens Not Applicable

Detailed Description:
32 patients with moderate to severe dry eye will be enrolled in this short-term proof of concept study to determine the efficacy in using soft lenses made of Senofilcon A in reducing signs and symptoms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial to Determine Whether Senofilcon A Lenses Provide Relief of Symptoms and Signs in Patients With Moderate to Severe Dry Eye Disease
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases


Intervention Details:
  • Device: Senofilcon A contact lens
    Senofilcon lenses will be tested in moderate to severe dry eye patients to determine their efficacy in reducing discomfort associated with dry eye.


Primary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI) [ Time Frame: 2 weeks ]
    Patient questionaire



Information from the National Library of Medicine

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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:

  • Confirmed diagnosis of moderate to severe dry eye associated with either Graft-versus-host disease (GVHD), Sjogren syndrome, idiopathic dry eyes, or minimal limbal cell deficiency
  • A baseline Schirmer tear test (1) of less than 5 mm at 5 minutes without anesthesia
  • Have a visual analog score for comfort of 50 or less (scale of 1-100, with 100 meaning perfect ocular comfort and 1 meaning severe ocular pain)
  • Ability or the resources to insert and remove the study lenses
  • An OSDI score greater than 42
  • A willingness to sign an informed consent

Exclusion Criteria:

  • No dry eyes or mild dry eyes
  • A baseline Schirmer tear test (1) of greater than 5 mm of wetting at 5 minutes
  • Dry eye comfort score of greater than 50 on a visual analog scale
  • Unable to insert or remove the study lenses (or have a family member do so)
  • Have an OSDI score less than 42
  • Has been diagnosed with neurotrophic keratopathy in either eye
  • Unwilling to enroll in the study, and unwilling to provide signed informed consent to participate in the study

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): NCT04096898


Contacts
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Contact: Timothy T McMahon, OD 312-996-5410 timomcma@uic.edu
Contact: Jacob Merriman 312-996-8041 jmerr@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Jacob Merriman    312-996-8041    jmerr@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Johnson & Johnson Vision Care, Inc.

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Responsible Party: Timothy T. McMahon, OD, Dr. Timothy T. McMahon, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04096898     History of Changes
Other Study ID Numbers: 2017-0941
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Timothy T. McMahon, OD, University of Illinois at Chicago:
dry eye
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases