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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 : March 24, 2020
Sponsor:
Collaborator:
Johnson & Johnson Vision Care, Inc.
Information provided by (Responsible Party):
Timothy T. McMahon, OD, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE April 23, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
Ocular Surface Disease Index (OSDI) [ Time Frame: 2 weeks ]
Patient questionaire
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
OSDI [ Time Frame: 2 weeks ]
Patient questionaire
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Senofilcon A Lenses in Moderate to Severe Dry Eye Disease
Official Title  ICMJE Clinical Trial to Determine Whether Senofilcon A Lenses Provide Relief of Symptoms and Signs in Patients With Moderate to Severe Dry Eye Disease
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Dry Eye Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2019)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Timothy T McMahon, OD 312-996-5410 timomcma@uic.edu
Contact: Jacob Merriman 312-996-8041 jmerr@uic.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04096898
Other Study ID Numbers  ICMJE 2017-0941
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Timothy T. McMahon, OD, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE Johnson & Johnson Vision Care, Inc.
Investigators  ICMJE Not Provided
PRS Account University of Illinois at Chicago
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP