Back to resultsSenofilcon A Lenses in Moderate to Severe Dry Eye Disease
Primary Purpose
Moderate to Severe Dry Eye Disease
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Senofilcon A contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Dry Eye Disease focused on measuring dry eye
Eligibility 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
Sites / Locations
- University of Illinois at ChicagoRecruiting
Outcomes
Primary Outcome Measures
Ocular Surface Disease Index (OSDI)
Patient questionaire
Secondary Outcome Measures
Full Information
NCT ID
NCT04096898
First Posted
September 18, 2019
Last Updated
March 23, 2020
Sponsor
University of Illinois at Chicago
Collaborators
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04096898
Brief Title
Senofilcon A Lenses in Moderate to Severe Dry Eye Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Johnson & Johnson Vision Care, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Dry Eye Disease
Keywords
dry eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Senofilcon A contact lens
Intervention Description
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 Measure Information:
Title
Ocular Surface Disease Index (OSDI)
Description
Patient questionaire
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy T McMahon, OD
Phone
312-996-5410
Email
timomcma@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Merriman
Phone
312-996-8041
Email
jmerr@uic.edu
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Merriman
Phone
312-996-8041
Email
jmerr@uic.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Senofilcon A Lenses in Moderate to Severe Dry Eye Disease
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